Product Development Engineer
Minneapolis, MN Posted: 10/16/2020
Mechanical Product Development Engineer
Contract | $50/hr+ D.O.Q.
Help fight the fight!
Konik PrimeStaff is partnered with a rapidly growing medical company that is working to fight cancer and Covid-19.
Due to their growth, they have a need to bring on a contract product development engineer to help develop novel and legacy products by helping with the design control deliverables, risk management activities, and design history file compliance.
Day to Day Activities Include:
- Manage deliverables from the design process including DHF and Engineering Project File documents
- Work closely with Quality and R&D engineering to assure appropriate requirement definitions are established
- Collaborate with design engineers and technicians in the development of verification/validation protocols
- Participate on design teams to assure customer product requirements as well as quality requirements are documented and addressed
- Collaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified
- Be a key contributor in problem solving efforts to identify and resolve challenging quality issues to ensure production of safe and effective medical devices.
- Complete reviews and audits of Design History File (DHF) documentation.
- Participate on design teams in the performance of FMEA’s and Risk Management activities
- Assist with the development of inspection processes and equipment when required
- Work with Manufacturing Engineering, Operations, and Quality, during concept, prototyping, and transfer of new products into production.
- Assure that design specifications are accurately translated into production/process specifications
- Other assignments as requested.
You bring to the table:
- Bachelor's Degree/Technical Degree in Engineering or equivalent experience
- Minimum 10 years' experience in a Medical Device manufacturing/product development environment
- Prior Medical Device Industry experience is required
- Experience/knowledge with product/process verifications/validations
- Experience with FMEA’s and Risk Management
- Experience with SolidWorks CAD program
- Problem solver with the knowledge of problem-solving tools, capable of facilitating the problem-solving process
- Strong project management skills and initiative
- Strong good verbal and written communication skills
- Strong technical writing skills
- Able to manage and prioritize multiple projects/objectives
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