Appendix E — Medical Device Systems Engineer Job Descriptions

Caution

The report published on this website is a draft and subject to frequent updates. Please be aware that the content may change over time as revisions are made. Thank you for your understanding.

Tip

If you have questions, comments, or feedback, please contact Esteban Solorzano.

esteban.solorzano@gmail.com

E.1 Job Description #1

You’ll have the chance to be a critical contributor on our Electrophysiology Systems Engineering team focused on delivering the future in Advanced Mapping technologies. This role will involve a range of responsibilities including but not limited to collaborating and leading teams in the development and analysis of system performance and system integration for our next generation products. In this role you will be a key member of a product development team to bring systems from concept to launch.

E.1.1 Responsibilities

Contribute to the technical and business strategy at the core team level for major system-level programs.
Utilize multidisciplinary engineering knowledge and experience to design, develop, and troubleshoot new products specific for cardiac mapping and ablation.
Provide system engineering leadership and take ownership for overall project success for new products from concept phase through launch.
Work with Product Marketing, Clinical Engineering, and Key Opinion Leaders to develop design input requirements from user and business needs.
Communicate to Sr. Management including technical presentations, status updates, and program reviews.
Lead project-level system architecture and system behavior definition activities utilizing use case modeling and other appropriate tools.
Lead cross-functional working groups to solve complex problems, mitigate risks, and develop strategies to overcome challenges.
Plan, manage, and report on overall systems integration activities including root cause analysis and solution generation.
Provide input into the technology and product roadmaps.
Be a strong team player and lead cross-functional teams to resolve issues and meet budget and schedule requirements.
Create a positive, collaborative culture amongst the technical teams while working to solve challenging engineering problems.
Mentor junior engineers.
Ensure compliance with procedural and documentation requirements, FDA, ISO and other regulatory bodies.

E.1.2 Required Qualifications:

Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related field with 10+ years of experience in developing highly complex electrical hardware, software, and signal-processing based systems.
Demonstrated ability to leverage and/or engage others to accomplish project goals.
Demonstrated ability to solve complex engineering problems and mentor other engineers.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to multitask, prioritize and meet deadlines in timely manner.
Strong organizational skills, as well as attention to detail.

E.1.3 Preferred Qualifications

Masters degree in Engineering and/or Science (could substitute for 2 years of engineering experience).
3+ years of experience as a Systems Engineer.
Medical device experience, specifically supporting cardiac mapping and/or ablation systems
Experience working in a broader enterprise/cross-division business unit model.
Detailed understanding of 60601 and other related electrical hardware regulations.
Experience in managing one or more direct reports.

E.2 Job Description #2

As part of the Engineering Organization, the Reliability Architect is primarily responsible for supporting the ongoing execution by helping establish Service Level Objectives of the different Engineering teams to achieve the business Reliability goals, You will refine performance targets, provide the strategic vision and reliability roadmap, lead design improvements, generate observability metrics targeting business and technical audiences, and enforce reliability best practices. You will maintain the Surgery DFR process and drive the quality of the different business releases. This role is instrumental in ensuring that our products perform as specified and do not fail in the install Base. A high level of quality is expected from our products.

E.2.1 Responsibilities

Identify process and infrastructure gaps to increase operational reliability.
Responds to production Install Base incidents and determine how we can prevent them in the future.
Partner with other Engineering team leads to bring best practices and enforce the DFR process.
Train the organization on the Surgery DFR process.
Triage testing data to work with the Software and Hardware teams to address issues. Ensure reliability growth to fulfill the reliability goals of the final product.
Facilitate Technical discussions during the Development phase to address the resolution of issues.
Participate in the review of Hardware test plans definition and Technical Reviews to promote good reliability practices.
Build and support Automated Testing Infrastructure.
Develop an adequate System level understanding of all the Surgery platforms and products.
Supports the monitoring of software performance over the development of the products.
Partner with other SREs to have a common strategy to implement the DFR process in the different programs.
Create team mechanism(s) to follow up on the activities of the other SREs to look for reliability progress, potential needs, or issues.
Define the adequate SLOs of the Software and Hardware Teams.
Develops Technical papers to define the necessary statistical methodologies to implement the DFR process.
Define a common strategy for the System level reliability technical reviews and ensure the proper flow down to the other Engineering reviews.
Work with the Functional Engineering Managers to define the resources and timelines required to execute the defined SLOs.
Participate with the GE HealthCare Reliability Central Team, defining and promoting good reliability practices.
Provides necessary information to Upper Management to make decisions around quality during the development and conclusion of the programs.
Work with global Surgery reliability leads to the exchange of data or work in initiatives.
Develops new automated testing strategies customized by the program; this will include the ability to adapt the infrastructure to new statistical approaches.
Triage Install Base information such as service replacements to identify the opportunities for improvements. Additionally Supports the Service team in the understanding of Install Base issues.
Participate with the Complaint Handling Unit team in triaging information to understand the baseline of the new products and the level of effectiveness of the active projections.

E.2.2 Required Qualifications

Bachelor’s degree in Systems Engineering, Reliability or Science in STEM degree.
Minimum 6 years of experience in product development or research development environment.
Experience in data and trending analysis.
Experience in reliability statistical methodologies.

E.2.3 Preferred Qualifications:

Master’s degree is a plus.
Experience in Medical or other Regulated Industries.
Reliability Certification.
Demonstrated Strong problem-solving skills.
Demonstrated ability to set and meet tight deadlines and function well under pressure.
Ability to work in a dynamic and fast-paced environment.

E.3 Job Description #3

The Principal Systems Engineer provides technical leadership, direction, and expertise in the design and development of instruments, software, or automation used in clinical laboratories to perform diagnostic tests. The Principal Systems Engineer works with project leads and teams to ensure that user, customer, and business needs are correctly translated into system and component level architectures, then selects technologies and designs module and system functions to create design specifications that can be implemented in a robust and verifiable manner. This role may also be responsible for supervision or mentoring of engineers.

E.3.1 Responsibilities

Create and determine hardware and software architectures and workflows at system and component levels.
Define and detail component functions, interfaces, signal, data, and information flows.
Actively engage with key stakeholders to comprehend the spectrum of available technology options and collaborate on their integration and application to products.
Evaluate and select technologies needed to meet design goals.
Communicate pros and cons of technology and design options and reasons for selection.
Champion introduction, learning, and implementation of new technologies.
Conduct creative analyses and high-level decision making.
Communicate and document designs and lead design and technical reviews.
Collaborate with cross-functional teams responsible for the design and development of clinical diagnostic products to meet product design goals while maintaining compliance with the quality system requirements.
Lead system development decisions affecting product development issues.
Lead the process to identify problems, investigate alternatives, and collaborate on the ideation and confirmation of potential solutions.
Serve as the technical lead on preparing reports and analysis and interpretation of data and results as related to system/software/hardware development and improvement.
Actively participate with research and technology efforts to ensure alignment with strategic priorities.
Prepare reports and analysis of results related to product performance improvements.
Report status of assigned projects through the preparation of detailed reports and documentation that summarize progress and performance results.
Interpret results of experiments and trials and recommend alternative approaches.
Create, review, and approve design history file documentation.
Present information and updates at project or departmental meetings.
Work within established project timeframes.
Manage external vendors to meet part and assembly design specifications.
Apply excellent attention to detail and meticulous record keeping.
Apply excellent analytical, problem solving, organizational, and decision-making skills.
Ability to work collaboratively with scientists, engineers, and software programmers.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company’s Quality Management System policies and procedures.
Maintain regular and reliable attendance.
Ability to act with an inclusion mindset and model these behaviors for the organization.
Ability to work nights and/or weekends, as needed.
Provides technical leadership, guidance, training, and mentoring.
Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
Ability to comply with any applicable personal protective equipment requirements.
Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
Ability and means to travel between Exact Sciences locations.

E.3.2 Required Qualifications

Ph.D. in Engineering or field as outlined in the essential duties; or Master’s Degree in Engineering or field as outlined in the essential duties and 4 years of experience in lieu of a Ph.D.; or
Bachelor’s Degree in Engineering or field as outlined in the essential duties and 8 years of experience in lieu of a Ph.D.
10+ years of experience working in a biotech/IVD/medical device related setting.
Demonstrated ability to work in a senior role with a well-established IVD or medical device company.
Demonstrated ability to work with CFR 21 part 820 and ISO 13485 compliance for software and instrumentation development.
Demonstrated ability to contribute to the development of successful medical device products.
Demonstrated ability to work with assembly, integration, troubleshooting, and testing custom equipment and instrumentation.
Advanced knowledge of engineering software tools used in a specific engineering discipline.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

E.4 Job Description #4

In this position the Systems Engineer will be the primary technical lead and decision maker for a variety of medical device projects from the early concept phase to design, realization, test, and production. This is a dynamic role that adapts to the needs of clients, the user, and technical challenges as projects progress.

The ideal candidate for this role will thrive on solving challenging problems, have the ability to strategize a creative path forward, and communicate technical information effectively to several audiences. An individual with strong experience with cross-functional, technical team leadership in an Engineering arena with an emphasis on creating, documenting, and communicating system architecture and requirements while actively driving the technical direction of a product team. This individual should be well-versed in translating client needs into technical descriptions that can be built and verified, and possess the ability to then distill the technical implementation into real-world implications to the business, clients, and the users. The ideal candidate would be willing to lean in and strategically guide the customer towards a well-balanced product within a business context.

E.4.1 Responsibilities

Organize the technical approach, architecture, requirements, and the technical team to communicate and execute product development strategies to the client and across our internal teams to realize well designed medical products that positively impact patient outcomes.
Create work proposals for new clients detailing technical approach, scope and work estimates.
Assess client project inputs to generate requirements, system architecture and design documentation.
Conducts analysis, review, and/or evaluation of design alternatives across various technologies and multiple disciplines.
Assigned to substantial tasks on major projects of high complexity (assignments may be broad in nature and require creativity and ingenuity).
Works to influence organizational direction while leading other engineers while leading a multidisciplinary, integrated team.

E.4.2 Required Qualifications

Bachelor’s or Master’s degree in Software, Electrical, Biomedical or Mechanical Engineering.
6+ years of experience in developing electronic-based devices or complex electromechanical systems.
Experienced with requirements writing and multidisciplinary, technical team leadership
Proficient at quickly solving high-complexity system-level problems.
Experience in interpreting and applying technical regulatory requirements.
Strong interpersonal, communication (both written and oral) & analytical skills coupled with excellent interpersonal skills with multiple disciplines & clients.
Strong emphasis on the ability to work independently, while also functioning as a team player.

E.5 Job Description #5

The Principal System Engineer position is a key technical leadership role at BMT and will integrate inputs and outputs to support the definition and development of complex software systems involving software services and multiple electro-mechanical medical device products. As design owner of a product solution, you are responsible for ensuring that your solution is built in accordance with customer, business, and regulatory requirements. This is done by effectively translating product requirements to design outputs, managing technical risks of the product, and following the technology roadmap. This position typically overlaps many technical and human-centered disciplines, including industrial engineering, functional engineering, human factors, marketing, regulatory affairs, quality assurance, and project management; a strong candidate will demonstrate a keen ability to facilitate cross-functional collaboration. The engineer is a key leader in development and management of support activities such as technical planning, systems integration, verification and validation, cost and risk, life-cycle management, and effectiveness for total systems.

E.5.1 Responsibilities

Ensure the logical and systematic translation of user and project needs into a comprehensive set of system and sub-system requirements in collaboration with the technical design leaders.
Take technical ownership of the product throughout its lifecycle and provide effective technical leadership to the product and engineering teams.
Resolve technical challenges by providing technical guidance to the product and engineering team through rigorous trade-off analysis to create robust and effective solutions.
Facilitate cross-functional technical decision-making and optimize the balance between technical and schedule risk with the cost targets of the product lifecycle needs.
Lead the integration of systems and devices, ensuring that the product meets the user and system requirements.
Demonstrate the traceability of requirements through Validation and Verification.
Lead the risk, hazard, and timeline analysis in to quantitatively evaluate design concepts & solutions
Plan, coordinate, and manage system and cross-system design activities and interface directly with the product leadership team on project issues and status.
Integrate sound design principles and standards into your programs including Design for Reliability, Manufacturing, and Service.
Identify user groups, environments, use scenarios and critical tasks for task analysis, instructions, guides, user training and system verification
Engage with the test teams to ensure plans for verification and validation activities are successful.
Mentor other members of the organization on hospital connectivity and interoperability.
Initiate and lead activities such as Failure Modes and Effects Analysis (FMEA) that identify design issues and lead the team in developing mitigations to address these issues.
Help the team members in developing high-quality documentation for all phases of product development, including design specifications, verification test plans, project schedules, and change orders associated with medical devices.
Partner with the functional technical leaders (Architects/Principals) to develop significant and impactful Intellectual Property to fuel the growth of the business.
Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation.
Develops products that meet requirements regulated by FDA, EU regulatory body, Pharmaceuticals and Medical Devices Agency (PMDA) and other governing bodies as defined by product management.
Commit to fostering and driving an environment and work output based on continuous improvement.

E.5.2 Required Qualifications

Bachelors’ degree in Engineering, or other scientific discipline, preferably computer, software, or control engineering.
10+ years of engineering experience.
3-5 years new product development and exposure to systems engineering roles.
2+ years of working with development of software products.
Demonstrated experience with Enterprise Architecture and Systems Engineering.
Technical Risk Management & Mitigation for Cloud-hosted solutions in Medical Device “connected” domain.
Knowledge of network concepts and use, including firewalls, VLANs, routing, VPNs, etc.
Experience with hospital system connectivity, including PACS, HIS/RIS, EMR.
Experience interfacing with Hospital IT customers, Radiologists, and imaging technicians.
Experience with network authentication solutions.
Demonstrated experience with risk management and systems engineering processes.
Demonstrated ability to clearly and accurately translate needs and requirements.
Ability to grow productive, trusting, and open relationships with a wide variety of constituencies.
Excellent communication, influencing skills and ability to gain buy-in for initiatives.
High degree of organizational skills and high attention to detail.
Ability to handle multiple tasks and prioritize effectively.
Ability to work both independently and as part of a team.
Ability to develop protocols, conduct system tests and write reports.
Strong initiative and passion about new technologies with high energy.

E.5.3 Preferred Qualifications

Graduate degree in Engineering (Software or Systems) or another scientific discipline.
5+ years of research and development experience.
Familiarity with Medical Device Interoperability.
Experience with IHE profiles relating to IT infrastructure and device communication.
Experience with Active Directory integration.
Understanding of IT system virtualization techniques.
Experience with Hybrid & Cloud Services, Cloud-hosted Data & Deployments.
Experience with hybrid cloud deployments.
Experience working with physicians and customers in a medical device product development role.
Experience with product concept development, customer interaction, systems engineering, verification of engineering requirements, and validation of customer needs/design requirements.
Experience with risk management and systems engineering processes.
Ability to translate needs and requirements clearly and accurately.
Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical, human factors and software.
Voice-of-customer experience and fluency with clinical radiology terminology.

E.6 Job Description #6

We are recruiting a Senior Systems Engineer to join our team where we are focused on helping people with heart failure manage their health and ultimately change and save lives. The engineer will be primarily working on the CardioMEMS HF portfolio, which remotely monitors changes in pulmonary artery (PA) pressure, an early indicator of the onset of worsening heart failure, to aid physicians in preventing worsening heart failure, lower heart failure mortality rates, and improve quality of life for our heart failure patients. The role is responsible for executing product development and systems engineering tasks for a wide range of CardioMEMS products including implantable sensors, external reader systems used by clinicians and patients, mobile application software, and cloud-based web applications. This person will participate and lead tasks in development of new programs and next generation products, including system design and architecture, requirements definition and management, design documentation, and system testing, verification, and validation.

E.6.1 Responsibilities

Plans, develops, and executes system verification based on established system requirements.
Drives review and optimization of project-wide and cross-project verification efforts to ensure adequate coverage, minimize duplication, and increase transparency and understanding of system - verification versus sub-system verification versus other types of testing.
Contributes to and supports gathering, analyzing, and reviewing system level and sub-system requirements.
Clearly documents test procedures and related material. Effectively documents test results, prepares test reports.
Participates in broad cross-functional reviews of work output. Presents at design reviews, documents and resolves associated issues.
Participates in risk management activities.
Identifies tools, fixturing, and other resources necessary for system verification. Contributes to development, documentation, and validation of tools and fixtures.
Applies industry best practices and applicable regulations to work area.
Gathers information, frames problems, provides status and progress, and adjusts/measures success within scope of responsibility to improve development efforts. Applies skills to planning product - development and testing work; capturing requirements, designing solutions, defining behaviors, investigating issues, evaluating trade-offs, and validating output under direction of another engineer for complex projects and independently for smaller projects.
Participates and supports implementation, development, enhancements, and modifications to existing and new products.
Debugs, troubleshoots, and isolates problems, as well as offers strategic solutions, analysis, and advice regarding identified issues. Conducts root-cause analysis of failures and product issues.
Develops and applies an expert understanding of designated systems as well as serves as a subject matter expert for the development team regarding behaviors, implementation, customer needs, clinical applications, and system and sub-system verification methodologies.
Communicates effectively with cross-functional teams and project management. Keeps leadership informed of progress and issues.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

E.6.2 Required Qualifications

Bachler’s Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or related discipline.
7+ years of in a similar position, including systems engineering and integration experience (integrating all system components, electrical, mechanical, software), system architecture, requirement/user need gathering, end-to-end (ideation to commercialization) technical product development experience, and/or system-level verification.

E.6.3 Preferred Qualifications

Advanced degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or related discipline.
Experience and expertise with systems consisting of hardware, software, mobile app, and cloud components.
Experience and expertise with systems with RF, electromagnetics, ASICs, Bluetooth, and NFC technologies.
Class III implantable medical device experience, specifically supporting heart failure and/or cardiovascular systems and experience with biologic sensors (flow, pressure, EKG, etc).
Strong knowledge of a development process consistent with ISO, FDA design control standards or requirements, and risk management practices.
Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs.
Ability to work within a team and as an individual contributor and leader in a fast-paced, changing environment.

E.7 Job Description #7

As a Senior Principal Systems Engineer on our Exploratory and Innovation team you join a talented and diverse group of engineers and scientists in the identification and early-stage development of new novel approaches to the treatment of kidney disease.

E.7.1 Responsibilities

Partner with our commercial and medical teams to identify and prioritize user needs, lead development of concepts to address those needs as well as the testing and analysis to demonstrate feasibility of the most concepts.
Directly contribute to the identification of unmet user needs and new approaches to addressing user needs through direct interaction with our customers and patients.
Lead Brainstorming sessions and ideation workshops to generate new ideas and concepts for innovative products, technologies, and solutions.
Work within the R&D organization to define and implement innovation strategies, multi-generational product plans, and technology roadmaps to enable successful delivery of innovation to the marketplace.
Bring rigorous critical thinking to ensure that key “killer” questions are addressed early in exploratory through best-in-class application of modeling, analysis, and empirical methods.
Foster collaboration and partnerships with internal teams, external research organizations, academia, startups, and industry partners to accelerate innovation and leverage complementary expertise and resources.
Identify and protect intellectual property through patent filings and strategic partnerships to create and safeguard innovation.

E.7.2 Required Qualifications

Graduate or Post-Graduate in Biomedical, Chemical, Mechanical, Electrical Engineering or related discipline. An advanced technical degree preferred.
Experience should include 8-10 years of relevant technical experience, including 5 years of leadership experience. Prior experience in the Renal Care domain is a plus.
Must possess a strong knowledge of engineering disciplines and solid knowledge of related disciplines, Electro/Mechanical, Systems, Fluid Mechanics, Sensing, Algorithm Development, etc.
A demonstrated track record in electromechanical system development and commercialization, preferably medical devices.
Recognized team player with proven facilitative leadership skills in a cross-functional global team environment. Proven performance in a matrix environment with ability to influence and align stakeholders.
Experience in leading small to medium cross functional teams with diverse backgrounds including engineering, clinical, sciences, and commercial.
Strong technical and problem-solving skills. Proven ability to make sound decisions, think critically and break down complex problems through application of first engineering principles.
Solid interpersonal skills. Ability to interact externally and internally to support business and innovation strategy.
Solid communication, presentation, and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
Creative thinking, curiosity, and passions for exploring new ideas and pushing the boundaries of innovation.

E.8 Job Description #8

This position is responsible for maintaining and enhancing the technical excellence of research and development work, including new product development, product sustaining, and manufacturing support. The primary role of the Principal Systems Engineer is to act as Technical Leader on development programs, leading all aspects of the technical execution of projects, assuming responsibility for technical project deliverables and working with Program Managers to assure successful project outcomes. The Principal System Engineer will also work with the engineering management team to ensure appropriate technological expertise.

Principal Systems Engineers will provide input to Program Managers and direction to other technical personnel and will assume appropriate level of responsibility for technical work to facilitate the development or manufacturing of world class products or assemblies.

E.8.1 Responsibilities

Understand and communicate best practices of Systems Engineering.
Experience with combined hardware, software system architecture. Ability to determine appropriate system architecture and include necessary safety mitigations.
Provide expertise across functional groups to define product implementations and solve problems with the ability to clearly communicate key product risk/benefit trade-offs. Provide support across multiple projects and teams to define system implementation strategies.
Develop testable product and interface requirements that include support for necessary features and performance, and include considerations for human factors, product safety testing, regulatory submissions, product packaging, environmental conditions, manufacturing and service. Support the development of requirement templates for use across projects. Use of JAMA for requirements management a plus.
Frequent use and application of medical device technical standards, including but not limited to IEC 60601 family of standards, IEC 62304, and FDA guidance’s. Monitor the regulatory environment to be able to communicate updates.
Develop and review risk analysis’ including and specifically design failure modes and effects analysis (FMEAs), and hazard analysis compliant with ISO 14971. Support the development and training of risk analysis methods.
Conducts analysis, review, and/or evaluation of design alternatives across various technologies and disciplines. Develop strategies for assisting multiple projects.
Support and direct system integration activities. Direct and develop plans to solve integration issues.
Support testing activities including design verification. Direct and provide options for issue resolution.
Prepares and reviews design documentation and manufacturing documentation. Lead design reviews. Assist with review and development of documentation templates, particularly for compliance with standards.
Support medical device builds including prototypes, animal and human use devices, and production equivalent verification builds.
Support design and manufacturing transfer into production. Assist with improving transfer processes.
Familiarity with the product development process including the use of established procedures. Assist and review product development process updates.
Ability to work and direct internal technical teams while coordinating with external customer teams. Must be able to communicate tradeoffs between risks, benefits, and performance while considering impact on budgets and schedules. Must be able to provide budget estimates for ongoing projects.
Provides mentorship and direction to less-experienced engineers.
Provides marketing and sales support by communicating with potential clients including articulating the technical and development process. Provide task and development estimates in support of projects proposals.
Propose and develop process improvement initiatives.
Work with Engineering Managers to identify and obtain necessary technical expertise, training and resources to support a diverse range of new product development and support efforts.
Participate in medical device industry events and organizations to maintain awareness of developments and best-in-class practices in the industry.

E.8.2 Qualifications

Master’s degree in an engineering, technical or scientific discipline or equivalent experience.
10+ years experience in developing software and/or electronic-based medical devices.
In depth knowledge of FDA QSR’s, ISO13485, and IEC601 for medical devices.
Experience in interpreting and applying technical regulatory requirements to medical devices.
Strong mentoring skills.
Strong interpersonal, communication (both written and oral) & analytical skills.
Excellent interpersonal skills with multiple disciplines & clients.
Ability to work independently, but also function as a team player.