Sr. R&D Engineer



Advert ID



Brooklyn Park

Job Type




Salary Range

Based on Experience

No. of Openings


Branch Information

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



Job Description

A medical device client of ours is seeking a Senior or Principal Level R&D Engineer with a strong catheter development background. This position will serve as a lead for the product design group. Candidates MUST have prior hands-on knowledge within catheters, building first prototypes, and able to troubleshoot issues that may arise through development. This is a direct hire role located in Brooklyn Park, MN.


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

* Conduct, 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 Controls, Design Verification & 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, etc. throughout the product development lifecycle.

* Lead development technicians/operators to perform hands on prototyping or testing.


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

* 5+ years of medical device experience

* Knowledge of design controls, process development, and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies.

* 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).