Associate Device Engineer
Responsible for device lifecycle change management of on-market medical devices and combination products. Develop change management technical impact assessments, design and development plans, risk management documentation, design verification & validation plans, test methods and data analysis. Ensure design controls are documented in accordance with internal procedures.
- Execute device and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and to ensure device design integrity is maintained
- Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, Regulatory, and Quality colleagues
- Execute design change projects with guidance and according to internal procedures, track progress, and communicate status to group leadership
- Establish experimental protocols, conduct experiments, analyze results
- Support technical execution of Design History File (DHF) updates
- Establish and maintain relationships with internal production site colleagues
- Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material / processes / changes to assure reliability requirements are met, with guidance and supervision;
- Establish and review specifications / requirements for components, products and processes, with guidance and supervision;
- Support CAPA and Complaint investigations, as appropriate
- Bachelor's degree in Engineering, Science or other technical degree
- Basic knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products
- Experience analyzing patient/user impact
- Experience in a GMP regulated industry
- Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards
- Critical thinking, and problem solving skills
- An ability to work independently as well as a member of a team in a fast-paced environment
- Working knowledge of statistical methods for data analysis
- Experience with Computer Aided Design (CAD) software
- 0-2 years' experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role
- Engineering degrees
Other Job Details
Office-based role supporting virtual teams via webex and phone. Flexibility required when working with global colleagues in various time zones.
Must be able to travel up to 20%.
Last date to apply: November 11th 2020
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