Lead System Engineer for Diagnostic Devices
6 days ago
We're excited to announce an exceptional opportunity for a skilled Senior Systems Engineer to join our dynamic team at Pattern Bioscience. As a key member of our Hardware Engineering team, you will play a critical role in developing and transitioning our diagnostic device from development to production.
About the JobThe successful candidate will have a strong background in system engineering, with 6+ years of industry experience in new product design and development for medical devices or in-vitro diagnostics. They will be responsible for leading development of verification protocols, analyzing performance metrics, and guiding the qualification of diagnostic devices for clinical evaluations.
In addition to their technical expertise, the ideal candidate will possess excellent communication skills, with the ability to effectively collaborate with cross-functional teams, including design engineers, software developers, and quality assurance specialists.
Responsibilities and Requirements- Lead development of verification protocols and completion of testing alongside software, mechanical, and electrical engineering teams
- Analyze performance metrics across diagnostic devices to inform design changes and updates to manufacturing processes
- Guide and support qualification of diagnostic devices for clinical evaluations
- Bachelor's degree in Mechanical, Electrical, or Biomedical Engineering; Master's degree preferred
- 6+ years of industry experience in new product design and development for medical devices or in-vitro diagnostics
- Thorough knowledge of FDA or industry standards, such as ISO 13485, 21 CFR Part 820, ISO 14971, ISO 61010, and/or ISO 60601
We offer a competitive salary range of $140,000 - $160,000 per year, based on experience, plus a comprehensive benefits package, including health insurance, 401(k) matching, and paid time off.
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