Quality Engineering Program Manager, Post Market
Medtronic
Design Engineer
Alphatec Spine
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $75,000 - $90,000 per year
Job Level
Junior
About the role
- Enhance existing products on the sustaining team under routine supervision
- Create concepts and model and draft designs utilizing 3D CAD software (SolidWorks)
- Draft design history file (DHF) documents and generate design assurance documentation
- Develop test plans and generate protocols for testing and analyzing new and current products
- Assist development processes for Manufacturing, Quality Control, Regulatory and Planning for projects
- Design and develop implants and instruments and assist in new product and manufacturing process development
- Develop working models for design evaluation and collaborate on development of inspection methods
- Initiate design changes for manufacturability while maintaining critical features for in-house manufacturing or vendors
- Serve on cross-functional product development teams from concept through product launch
- Provide technical input to Marketing and Sales and support Regulatory Affairs for FDA 510(k) submissions and international registrations
- Create and process Change Orders (COs)
- Other duties as assigned.
Requirements
- Experience with 3D CAD software, preferably SolidWorks
- Strong verbal and written communication skills; comfortable presenting to senior management
- Knowledge in the use and interpretation of geometric dimensioning and tolerancing, preferred
- Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics, preferred
- Undergraduate degree in mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics
- 1-4 years of product development experience, preferably in spine or implantable orthopedic medical devices
- For U.S. roles requiring access to hospital facilities, must be eligible for and maintain hospital credentials, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable)
