We are partnering with an innovative medical technology company focused on developing solutions that improve patient care. Their groundbreaking products aim to address critical treatment side effects, and they are seeking a Senior Design Assurance Engineer to provide quality expertise across their product portfolio. This is an exciting opportunity to contribute to the development of life-changing medical devices within a multi-award-winning team.
Key Responsibilities:
- Support Design Verification and Design Validation testing, ensuring methods are robust and effective.
- Lead or support corrective and preventive actions to enhance designs and test methods.
- Drive the Design Controls process and facilitate Design Reviews.
- Assist with compiling technical documentation for regulatory submissions.
- Support the development of test methods and work instructions.
- Contribute to Human Factors and Usability studies.
- Facilitate smooth transitions from design to manufacturing, including transitioning dFMEA to pFMEA and test methods to process test methods.
- Collaborate with internal teams and external design/manufacturing partners and suppliers.
Key Requirements:
- Qualifications: Engineering, scientific, or technical degree (ASQ CQE accepted).
- Experience:
- 3+ years in Design Assurance or R&D, ideally within an ISO 13485 QMS or equivalent environment.
- Strong experience with design controls, design reviews, and design change processes.
- Proficient in FMEA and problem-solving/root cause investigations.
- Technical Skills:
- Proficiency with statistical tools and MS Excel/Word.
- Communication Skills:
- Strong written and verbal communication, comfortable engaging with internal and external stakeholders.
Desirable Skills (Nice to Have):
Process or test equipment validation experience.
- Previous experience in a startup or SME environment.
- Experience optimizing processes with a focus on Design for Manufacturability (DFM).
- Validating test methods, test equipment, or test software.
- Background working with sterile devices, electro-mechanical equipment, or devices containing software.