Job Summary
This position is responsible for leading and/or participating in projects focused on design modifications of devices post-release to market, aiming to maintain device quality and compliance while reducing costs and increasing yields.
Responsibilities
* Lead or participate in CAPA or Design engineering projects, collaborating with other Post Market / Manufacturing Engineering Teams to ensure project completion and objective achievement.
* Ensure effective reporting to the Team Lead, Post Market Engineering, building strong relationships with Production, Quality, and Regulatory Affairs teams.
* Support or lead the delivery of CAPA or Design projects/deliverables, including investigation, root cause analysis, corrective/preventative action implementation, verification of effectiveness, and timely completion.
* Support projects focused on design changes, cost reduction, yield/efficiency improvement opportunities, and regulatory submissions/resubmissions.
* Maintenance and remediation of Design History Files, risk management files, and post-market surveillance of devices, complaint investigation, and risk analysis.
* Provide engineering support for post-market clinical studies as required.
* Ensure compliance with Cook's Code of Conduct, Quality System requirements, and Company HR policies, liaising with other Cook manufacturing facilities as needed.
Qualifications
* Bachelor's degree in engineering or a related field, or relevant experience.
* Minimum 3 years' relevant experience required.
* Strong project management skills, interpersonal skills, communication across functions, and problem-solving skills.
* Knowledge of medical device quality standards (ISO13485/FDA), GMP, and regulated industry standards.
* Proven ability to work independently and collaboratively, with strong organizational, collaboration, and team-building skills.