Product Transfer Reconstructive Sports Medicine Products
Great companies are always looking to improve process and enhance outcomes. Our client is adding a New Product Introduction/NPI Engineer to the team.
If you possess strong leadership and organizational skills along with creative problem solving; this opportunity could change the trajectory of your career!
Our client manufactures medical textiles for tissue to tissue or tissue to bone repairs. They are a world-wide leader in design and delivery in this marketplace.
This is a critical fill and interviews will be scheduled immediately. Those chosen will have competitive salaries, bonus, solid benefits including healthcare, 401k, relocation assistance, and more. This client promotes from within and recognizes those who do their jobs well.
- Continuous improvement in processes.
- Communications to upper management
- Project management skills PMP a bonus
- Conducts Management Review process in accordance with ISO standards.
- Working knowledge of standards and regulations ISO 13485, FDA 21 CFR Part 820
- Understanding of IO/OQ/PQ
- Able to interpret technical drawings, blueprints, specifications, illustrations, and written documents
- Validation representative for audits requirements (FDA, ISO)
- 25% Travel to Mexico
- BS in Engineering, Manufacturing, Mechanical, Biomedical
- 7+ years in medical device or pharma (sterility assurance a plus)
- A background in Sports Medicine, Machining, or Project Management
- Regulatory Compliance experience ISO13485 IQ/OQ/PQ
- Experience in injection molding
- Past experience in setting up a manufacturing operation (a plus)
- Documenting and reporting the analysis of test results
- Problem solver with strong written and verbal communication
- Provide critical analysis to upper management
- Review SOP’s and recommend improvements
Experience standards and regulations ISO 13485, FDA