Sr. Systems Engineer

The role

You will work with the engineering team to develop software for next generation Inspire products. You will translate stakeholder needs into system-level design inputs and manage system design, requirements, and lifecycle management.

What you will do

• Translate stakeholder needs and use cases into system-level design inputs.
• Define, evaluate, and maintain system design, functional decomposition, and performance budgets.
• Develop, review, and manage stakeholder needs and product requirements.
• Lead or contribute to design and technical reviews.
• Create product risk management deliverables in compliance with ISO 14971.
• Support design transfer activities to manufacturing.
• Support new product launch planning.
• Monitor product performance and support complaint investigations.
• Support technical problem solving including CAPA investigations.
• Communicate and negotiate with internal teams and external customers.

Required qualifications

• 5+ years of work experience in systems, software or signal processing (3+ years with Master’s degree)
• Ability to specify, design, implement, verify, validate, and support high quality design features
• Ability to perform statistical analysis
• Experience developing tools in MATLAB, Python, and C++ languages or equivalent
• Bachelor’s degree in biomedical, software, computer science, or related field
• Medical device product development experience
• Experience with industry standards such as ISO 14971, ISO 14708, EN 45502, IEC 60601, IEC 62304, IEC 62366 etc.
• Understanding of 21 CFR 820 requirements and ISO 13485 requirements

Nice to have

• Understanding of systems engineering processes and practices
• Understanding of mechanical, electrical and embedded signal processing algorithms for physiologic signals
• Understanding of software and systems considerations for clinical research
• Master’s degree in biomedical, software, computer science, or related field

Benefits

• Multiple health insurance plan options
• Employer contributions to Health Savings Account
• Dental, Vision, Life and Disability benefits
• 401k plan + employer match
• Identity Protection
• Flexible time off
• Tuition Reimbursement
• Employee Assistance program
• Equity awards
• Employee Stock Purchase Program

About the company

Inspire Medical Systems is a medical device company that develops products for those living with Obstructive Sleep Apnea (OSA).