Role OverviewThe Senior Software Systems Engineer will partner with cross-functional development teams to ensure software and system-level design activities are planned, executed, and documented in compliance with applicable quality and regulatory requirements. This role supports new product development by providing quality oversight and technical guidance throughout the design control lifecycle, with a focus on software-intensive medical device systems.
What You Will Do
Provide design quality support for software and software-enabled medical device development programs from concept through transfer to manufacturing. Ensure compliance with applicable design control, software lifecycle, and risk management requirements. Review and contribute to system requirements, software requirements, architecture, and design documentation.
Why It Might Be a Fit
The ideal candidate combines strong systems engineering and software development knowledge with experience in design controls, risk management, verification and validation, and regulatory expectations for medical device development.
Requirements
- Bachelor's degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field
- minimum of 4 years of relevant experience
- demonstrated experience with design controls, software development lifecycle activities, and verification/validation
- strong understanding of risk management principles, design failure analysis concepts, and traceability across requirements, design, and testing
- experience supporting cross-functional product development teams
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan
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