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Job Description
Lead Post Market Engineer responsible for design modifications of devices post release to market, ensuring quality, compliance, cost reduction, and yield improvement.
Reporting to the Team Lead, Post Market Engineering, the successful candidate will lead or participate in projects focused on design modifications, collaborate with other teams, and ensure effective reporting.
Key Responsibilities:
- Lead or participate in CAPA or Design engineering projects
- Collaborate with Post Market / Manufacturing Engineering Teams to ensure effective completion of department projects / objectives
- Ensure effective reporting to the Team Lead, Post Market Engineering
- Work closely with Production, Quality, and Regulatory Affairs teams to build effective relationships
- Support / lead the delivery of CAPA or Design projects / deliverables
- Verify effectiveness of CAPA's and ensure timely completion
- Collaborate with CAPA / Process owners to provide guidance on investigation, root cause analysis, and corrective / preventative action
- Support projects focused on design changes, cost reduction, and yield improvement opportunities
- Support Regulatory Affairs with engineering input for design related submissions and resubmissions
- Maintain Design History Files and Risk management files for existing devices
- Support post market surveillance of devices, complaint investigation, and risk analysis
- Provide engineering support for post market clinical studies
Qualifications:
- Bachelor's degree in engineering or a related field and / or relevant experience
- Minimum of 3 years' relevant experience
- Strong project management skills
- Strong interpersonal skills and ability to communicate across functions
- Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards
- Proven problem-solving skills
- Good computer skills including knowledge of Microsoft Office
- Strong organisational, collaboration, and team building skills
- High self-motivation
- Willingness and availability to travel on company business