Senior Quality Engineer (Electrical & Software Engineering)

The Senior Quality Engineer will contribute to product specification development, quality planning, and ensuring compliance with regulations. Responsibilities include documentation, software validation, testing, and troubleshooting, supporting production runs and customer issues. Collaboration with regulatory bodies and contract manufacturers is key to maintaining quality standards.

Requirements

• BS in electrical, software Engineering, or equivalent biomedical Engineering with software engineering experience
• Minimum seven (7) years of experience, preferred with related medical device experience
• Understanding of regulatory requirements for the medical device industry (IEC 60601, IEC 62304, 21 CFR 820, ISO 13485, ISO 14971, and HIPPA)
• Proficiency with PC-based office computers, Microsoft Office suite
• Strong foundation in education, skills in electrical and software engineering
• Expert in tools and processes for root cause analysis
• Ability to work independently, using good judgment, initiative and analytical abilities
• Ability to work as a team member
• Self-motivated and self-directed

Benefits

• Medical, dental, and vision insurance provided at no cost
• 401(k) matching plan
• Paid Time Off
• Competitive salary with opportunities for career growth
• Employee stock options
• Life & AD&D and long term disability insurance
• Education assistance
• Voluntary commuter benefits and pet insurance
• Weekly company lunches and occasional happy hour events