Senior Systems Engineer
On-site · Audubon, Pennsylvania, United States
Job Summary
Senior Systems Engineer to design, develop, and deliver high-reliability mechanical components and assemblies for Class III implantable neuromodulation systems and external accessories; lead system architecture decisions, guide cross-functional design activities, ensure compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance on usability and cybersecurity; perform human factors engineering, system verification and validation, risk management, and regulatory compliance across the full product lifecycle; provide technical guidance to teams, coordinate activities across the systems engineering function, and travel up to 10%.
Required Qualifications
- Bachelor’s degree in Software Engineering, Computer Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Systems Engineering, or equivalent degree/major required
- 8 years experience with Bachelor’s, 6 years with Master’s, or 3 years with PhD in development or verification in the medical device industry (Class III medical device experience preferred)
- Experience in a regulated industry (medical device, defense, or automotive)
- Experience in Systems Engineering including stakeholder needs definition, use case workflows, requirements decomposition, functional architecture, system design
- Experience generating technical documentation (product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports)
- Experience with RF communications systems desirable
- Usability engineering (human factors) experience strongly desired
- Risk management experience strongly desired
- Cybersecurity in medical devices experience strongly desired
- Project management skills including planning and estimation of tasks, milestones, resources, and budget desired
- Willing to travel up to 10% as needed
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