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Job Description

This client is a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and rigorous research. We are seeking a highly skilled and motivated Systems Engineer to join their team.

This role will be directly responsible for Design History File (DHF) remediation activities for the SmartDrive MX2+ project, ensuring all documentation and processes meet current regulatory and internal quality system requirements. This person will be responsible for understanding the product’s technology, intended functionality, design architecture, constraints, trade-offs, and risks, and they will use that understanding to drive efficiency and product quality into the ongoing development of the product. This will be done through responsibility for requirements management, risk management, and traceability remediation. This position is for someone who is goal driven and enjoys working in a dedicated cross-functional team environment and who is comfortable with navigating ambiguity and lack of process.

Essential Duties and Responsibilities:

• Work with upstream partners in Marketing and Scientific and Medical Affairs to refine excellent user needs statements and use-related risk analysis, setting the foundation for validation activities.

• Work with downstream partners in Product Development, facilitating the risk management process to yield risk controls driving design inputs

• Work with downstream partners in Product Development and Regulatory to draft high quality requirement sets, setting the foundation for verification activities for new product development

• Work with downstream partners in Test Engineering to define verification test strategy and protocols

• Ensure traceability throughout the project, ensuring that at every stage the “why” is well understood

• Performing other Systems Engineering tasks as necessary.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• Bachelor’s degree in engineering discipline

• 5+ years of engineering experience.

• Fundamental understanding of electromechanical systems

• Familiarity with Agile Methodology.

• Knowledge in ISO 14971, ISO 13485, and ISO 62304

• Proven adaptability to shifting priorities and ability to quickly assimilate new information or requirements as project needs evolve.

• Demonstrated ability to communicate and negotiate with a diverse group of cross-functional stakeholders in Marketing, Product Development, QA/RC, Sourcing, and Operations.

• Able to write clear, concise, and verifiable requirements.

• Proficiency with structured problem-solving.

• Able to plan, estimate, and accurately track technical deliverables.

• Adaptive, open to change, and continuously looks for ways to improve and simplify complex work Experience with an Electromechanical device (wheelchair) and (understand how electromechanical components work and how they get broken down )

Experience in Medical Device Design Controls