A prominent, global and multi-billion dollar company is seeking a R&D Product Development Engineer to lead the design team supporting the medical product line. This person will help lead the team to maintain existing products, processes, and specifications including modifications for new applications consistent with manufacturing techniques. The person in this role will also initiate and implement programs to continuously improve quality, and cost, while meeting customer requirements. The role may support and implement product extensions to existing platform products to meet specific customer requirements. This is a full time, direct hire position in the $140K+ range with 15% bonus and excellent benefits and 401K plan.
location: Andover, Minnesota
job type: Permanent
salary: $135,000 - 155,000 per year
work hours: 8am to 4pm
- Extensive experience/knowledge of phase gate design process
- Expert in writing protocols and reports for design verification, design validation, biocompatibility
- Expert in creating risk management files, DFMEA, UFMEA
- Extensive Understanding of medical standards ISO13485, IEC 60601, MDR, etc.
- Deep understanding and ability to apply medical standards to write Design Control Process, SOP's
- Knowledge of what is required for regulatory
- Lead innovation of new technology in medical product family.
- Create and complete advanced development projects (LEAP) Collaborate with design and manufacturing engineers as required Collaborate with manufacturing engineers and work with various vendors to identify processes required for a new design Technical Leader in Medical Products
- Experience level: Experienced
- Minimum 7 years of experience
- Education: Bachelors
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.