Medical Device Product Launch Specialist
2 days ago
Victrex Manufacturing Limited
Job Title: Medical Device Product Launch SpecialistEstimated Salary: $95,000 - $115,000 per annum
About the CompanyInvibio Biomaterial Solutions, a trusted partner to medical device manufacturers for over 20 years, is committed to delivering innovative solutions that make a tangible difference in people's lives.
The company has been successful in introducing new products, from long-term implants to drug delivery systems, and has positively impacted countless lives through its PEEK-OPTIMA polymers.
About the RoleThis role involves leading the development and implementation of new medical devices, ensuring quality, cost-efficiency, and timely delivery. You will work closely with Development, Manufacturing, and Quality teams to achieve this goal.
- Leading the development and implementation of new medical devices.
- Managing Design for Manufacture (DFM) processes to meet stakeholder requirements and targets.
- Validating new manufacturing processes and ensuring compliance with industry standards.
- Leading risk management processes in line with ISO14971.
- Generating and executing validation plans, including URS/DQ/IQ/OQ protocols, and overseeing handover to operations.
- Supporting feasibility studies with accurate manufacturing assessments and statistical analysis of process capabilities.
- A Bachelor's degree in Engineering or a related field.
- Proven experience in New Product Introduction, ideally within the medical device industry.
- Experience with equipment and process validation.
- Strong working knowledge of Continuous Improvement techniques, with a proven track record of process development.
- Excellent analytical skills and report writing, with experience of writing procedures and templates.
- Exceptional time and task management, with a thorough understanding of project management.
- A keen eye for detail, ensuring quality in every aspect of your work.
We offer excellent pay and conditions for the right candidate, along with full on-the-job training and support. Additionally, you can expect a competitive salary, private healthcare, 29 days holiday, and a generous company pension contribution.
We are an ambitious team dedicated to innovation in the medical industry, and we are looking for someone who shares our vision and passion for making a difference.
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