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.

Key Responsibilities:

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

2. 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.

3. Provides guidance to product and technology teams.

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

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

6. Develop and coach others
on
engineering documentation.

7.
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

• 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

Other Details
:

Schedule: 08:00:AM - 04:30:PM

Work Setup: Onsite — Arbor Lakes, MN

Contract Length: 12 Months (2/23/2026 - 2/22/2027) Possible Temp-to-Hire