Systems Engineer 2 Marlborough, MA

Job Summary:

The Systems Engineer II R&D GSS supports the development of complex medical devices by translating user needs into clear actionable requirements and assisting in system-level design and verification activities. The individual collaborates with cross-functional teams including marketing and clinical partners to gain an understanding of user and patient needs and supports the integration of subsystem interfaces. The Systems Engineer II applies understands the interfaces between multiple engineering disciplines (i.e. HW SW Mechanical) to support overall system integration verification testing methods and documentation traceability.

Essential Duties and Responsibilities:

• Maintains and builds a solid understanding of our products and their use in clinical practice.
• Supports architectural discussions to conceptualize clinical workflow and design solutions under the guidance of senior engineers. Authors architecture/interface documentation as necessary.
• Supports ensuring that product designs address specific user requirements for various clinical roles incorporating perspectives from multiple user groups.
• Contributes to team discussions on tradeoffs between different design directions and their impact on system performance.
• Assists in preparing product definition documentation by collaborating with Marketing to clarify user needs and draft product requirements.
• Helps to understand and document relationships between different levels of design inputs and outputs and supports the generation of matrices to communicate these relationships.
• Applies engineering principles to analyze internal interfaces within the system their interdependencies and their impact on product-level performance.
• Maintains a basic understanding of relevant standards for medical devices and their impact on design control elements (such as design inputs V&V testing and risk management).
• Supports the creation of V&V plans and participates in verification activities to ensure system-level requirements are met.
• Works with marketing and technical teams to deliver product value and provide input to the platform/product roadmap.
• Builds and maintains strong working relationships with Marketing Sales PMO Design Assurance Regulatory Affairs Clinical Affairs and other functional partners.
• Develops system level test methods validations and test equipment to ensure successful design verification.

Qualifications:

Education:

• Bachelors degree in Systems Engineering Mechanical Engineering Electrical Engineering Biomedical Engineering or related technical field preferred.

Experience:

• Preferred Minimum:; 3-4 Years
• Preferred Minimum Technical/Advanced Degree: 1-3 Years with Masters Degree

Skills:

• Foundational clinical and technical knowledge within the field of gynecological surgery or related medical device area.
• Ability to contribute to technical specifications and test methods.
• Ability to understand user needs and support validation activities.
• Working knowledge of Design Controls within the new product development process.
• Ability to assist in product risk assessment and understanding of risk management principles.
• Exposure to model-based systems engineering tools (e.g. SysML) to help document device architecture and interface management.
• Basic understanding of engineering principles and methodologies with experience collaborating across engineering disciplines.
• Familiarity with embedded systems and ability to work with both hardware and software teams.
• Ability to participate in root cause investigations.
• Strong verbal written and presentation communication skills; able to adapt communication for technical and non-technical audiences.
• Ability to work cooperatively in a matrix organization to accomplish project goals.
• Excellent interpersonal skills; collaborates cross-functionally and fosters a positive team environment.