Senior R&D Engineer — Medical Device; Onsite — Maple Grove,MN Temp Job Osseo area,Minnesota USA,Engineering

Position: Senior R&D Engineer — Medical Device (Onsite — Maple Grove, MN) Possible Temp-to-Hire

Job Summary

Independent conducts development work as part of a major research and/or development project. Receives minimal technical direction/review on broad scope or complex projects. Viewed as an expert in one or more in-house technologies.

Key Responsibilities

Work with a small team of new product design engineers focused on the design of a new large bore delivery catheter.

Works independently to develop key deliverables as part of a 510k regulatory submission. Deliverables include, but not limited to: CAD design, detailed print packages, specification generation and rationale, specification mapping to essential design outputs, DFMEAs, tolerance analysis, device material assessment(s), and bill of materials.

Provides guidance to product and technology teams.

Assesses the feasibility and soundness of alternative engineering processes, products, or equipment.

Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.

Develop and coach others on engineering documentation.

Demonstrates PDP/TPD system knowledge through coaching and delivery of high quality, high impact deliverables.

Requirements

Minimum of a bachelor’s degree in mechanical or biomedical engineering (or other related technical discipline)
5+ years of experience in design assurance, new product development or related medical device / regulated industry experience
Experienced in design controls, print packages, tolerance analysis, GD&T
Self-motivated with a passion for solving problems and a bias for action
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
Ability to effectively work and collaborate in a mixed onsite + remote environment
Demonstrated experience creating detailed technical documents

Preferred Qualifications

Experience working with medical devices such as catheter or delivery systems
Quality Integration experience
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Experienced problem solver, capable of facilitating the problem-solving process
Adaptable and effective collaborator in a team environment or in self-directed work
Experience with design changes, complaint reduction, and corrective action

Other Details

Schedule:

08:00:

AM - 04:30:

PM

Work Setup:
Onsite — Maple Grove, MN

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Senior R&D Engineer — Medical Device; Onsite — Maple Grove, MN Temp