Senior R&D Engineer — Medical Device (Onsite — Arbor Lakes, MN) Possible Temp-to-Hire

Pharmavise Corporation • Maple Grove, MN

1d • Onsite

About The Position

Our F500 Medical Device client has an exciting opportunity for a Senior R&D Engineer.

Job Summary:
Independently 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.

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

Nice To Haves

• Experience working with medical devices such as catheter or delivery systems
• Quality Integration experience
• 510k regulatory 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

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.

What This Job Offers

• Career Level: Mid Level