Our client is a product engine for a vertically integrated healthcare provider, developing implantable products in conjunction with surgeons to offer the best results for the patient. This design engineering position has high visibility & this person's work will have significant impact.
Roles and Responsibilities:
- Work directly with company leadership, engineers, and surgeons to develop design input guidelines for new surgical implant systems.
- Work directly with internal manufacturing team for prototype and development of implants and surgical instruments to support the rapid development of new implant systems.
- Responsible for contributing to design control documents, quality system documents and creating the design history file for FDA review through the 510(k) process.
- Design transfer and device master record maintenance.
- Participate in anatomic test labs with surgeons.
- Travel to surgical cases to gather input from and offer support to surgeons
Required Skills & Experience:
- BSME or similar technical discipline, such as Biomedical or Industrial design
- Previous experience in mechanical design within medical device - orthopedic, spine or dental preferred
- Experience in application of GD&T
- Proficient in SolidWorks
- Flexibility to work with conflicting inputs and resolve a solution to satisfy user requirements.
- Proficient in the design control process with knowledge of tracing design documents to product requirements including design inputs, outputs, verification and validation
- Knowledge of design history file, design transfer, and device master record maintenance
- Working knowledge of strength of materials commonly used for surgical instruments and implants [Stainless Steel, Titanium, Biocompatible Polymers]
- Working understanding of FDA 21 CFR QMS requirements, GMP, GDP, and ISO 13485
Versique is a high-performance recruiting firm based in Minneapolis, MN specializing in interim solutions, direct hire, and executive leadership search. We believe people are the ultimate business advantage. Our experienced functional recruiting teams work within a variety of areas of expertise (HR, Finance & Accounting, Demand Generation, IT, and Engineering) and broad industries (Healthcare, Banking, Consumer Packaged Goods, Manufacturing, Private Equity, and Family-Owned). Voted as a “Star Tribune Best Places to Work” three years in a row by our employees, Versique is one of the largest and fastest growing staffing and recruiting firms in the Midwest. The Versique brand represents a powerful combination of “versatile” and “unique” as it hints at the concept of “search” in its pronunciation: ver-seek.
Versique is an equal opportunity employer committed to creating a diverse workforce. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability, or veteran status, among other factors.