Sr. Product Development Engineer



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Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description

A client of ours in the medical device industry is seeking a Senior Product Development Engineer. The primary responsibility of this position is to design and develop medical products from concept through process validation. This individual will engage in product and process development for a variety of parts from components, to complex assemblies, to finished devices/systems. This position will work in a dynamic, innovative and collaborative environment including hands-on and customer-interfacing interactions. This is a direct hire opening located in Fridley, MN.

Position Responsibilities:

* Lead or contribute to design, development, validation activities through product life cycle for neuromodulation products in accordance to project scope

* Conduct &/or participate in brainstorming sessions to identify creative ideas and unique solutions.

* Execute deliverables for Design Control process to deliver the desired product to production in a cost-effective manner while hitting product performance and profitability goals

* Complete and manage Design History File(s), Design Control, Process Validation and all necessary activities in accordance to all internal and external processes, procedures and standards (MDR, ISO, EN, etc).

* Read and understand customer specification/requirements to translate into clear, concise performance and functional requirement.

* Develop strategy for robust design, process and testing criteria to satisfy requirements.

* Conduct engineering evaluation, characterization, design of experiments (DOE), bench testing or other verification activities to improve and confirm capability in the design and process.

* Assess, anticipate and mitigate risks through risk assessment tools such as FMEA, root cause analysis, and etc throughout the product development lifecycle.

Position Qualifications:

* Bachelor's Degree in Engineering or related technical field required.

* A minimum of 8 years of engineering experience with a minimum of 4 years in medical device products (neuromodulation experience and project/people management experience are a plus)

* Proven experience in 3D modeling (Solidworks preferred) and working knowledge of drafting specifications such as GD&T

* Experience in a regulated environment and demonstrated competence in required documentation and industry accepted practices such as Good Manufacturing Practices (GMP), ISO 13485 Design Control, and Quality Systems Regulation (QSR)

* Knowledge and effective application of engineering tools (Risk Analysis, FMEA, DOE, Process Validation, protocol/report documentation) required

* Familiarity with Process Instrumentation and Controls, development and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies.

* Excellent technical writing skills