Job Description
Pr. Product Development Engineer | Direct Hire | Arden Hills, MN | Med Device Industry | $105-$142k + bonus
Lead, interact and collaborate with project team members, engineers, researchers and customers to meet project goals and resolve issues. Responsible for taking customer designs and specifications and interpreting for process and QMS feasibility. Oversee prototyping and Product/Process Development of medical device assemblies including catheters and related sub-components. Conduct feasibility and reliability tests to evaluate designs. Translate customer clinical needs into detailed product and process specifications and drawings in accordance with regulatory safety standards. Collaborate with suppliers and external partners on sourcing of components and materials. Research and Integrate new technologies and materials by utilizing technical knowledge and implementing solutions. Create documentation including specification requirements, process work instructions, risk assessment, FMEA, BOM, drawings and test results. Draft and execute test protocols and present relevant results and findings to team, management and customers. Ensure yields are acceptable for manufacturability and product cost targets. Support the quoting/proposal process and predict project costs, material lead times and product delivery schedules.
Qualifications:
* Bachelor's Degree: Engineering realm
* 15 years of experience is ideal (have fairly inexperienced team) (mentor other engineers)
* Have to have medical device industry experience
* Cath is HEAVILY sought after, guiding introducer, medical device delivery, electrophysiology cath, Delivery system used to place a valve- that would fit
* Hands on medical device assembly
* Mechanical Engineering background
* Solidworks experience