What are the responsibilities and job description for the Medical Device Validation Engineer position at Trelleborg Medical Solutions?
About the Position:
Trelleborg Medical Solutions is looking for a seasoned Medical Device Validation Engineer to join their team. In this role, you will be responsible for ensuring that all medical devices meet the required quality and regulatory standards.
Main Responsibilities:
- Develop and execute equipment, software, test method, and/or process validation strategy in conjunction with the NPD team.
- Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA).
- Author or approve protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ).
- Collaborate with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards.
Requirements:
- A 4-year degree in quality, engineering, or any related field.
- 2 years in a manufacturing environment in a technical support role.
- Desired: ASQ Certified Quality Engineer, Formal Six Sigma Yellow/Green belt training, knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable).
What We Offer:
- Competitive compensation based on experience.
- Generous benefits package: Health, Dental, Vision, STD, LTD, Life, 401k.
- Paid time off.
- Bonus.
