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

Pharmavise Corporation; Osseo (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

Pharmavise Corporation is seeking a Senior R&D Engineer for an onsite role in Maple Grove, MN. The position focuses on leading development of a large bore delivery catheter, with responsibilities spanning CAD design, 510k documentation, tolerances and DFMEAs.

The ideal candidate will have 5+ years in design assurance or regulated medical devices, strong GD&T, and proven ability to create detailed technical documents while guiding cross-functional teams in a mix of onsite and remote work

Qualifications

• Requires a bachelor’s degree in mechanical or biomedical engineering or related field.
• 5+ years of experience in design assurance, new product development, or regulated medical devices.
• Experience with design controls, print packages, tolerance analysis, and GD&T.
• Self-motivated with strong problem solving and action bias.
• Excellent verbal and written communication; skilled in quality tools and methodologies.
• Ability to collaborate in a mixed onsite + remote environment.
• Proven ability to create detailed technical documents.

Responsibilities

• Work with a small team to design a large bore delivery catheter.
• Develop deliverables for 510k submissions: CAD, prints, BOM, specs, mappings, DFMEAs.
• Provide guidance to product and technology teams.
• Assess feasibility of alternative processes, products, or equipment.
• Coordinate and document project goals and progress; guide revisions.
• Develop and coach others on engineering docs.
• Demonstrate PDP/TPD knowledge through high quality deliverables.

Skills

Communication

Problem solving

Quality tools

Collaboration

Technical docs

GD&T

Change management

Regulatory knowledge

Education

Bachelor's degree in mechanical/biomedical engineering

Tools

CAD

DFMEA

Tolerance analysis

Job description

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

Osseo, United States | Posted on 02/05/2026

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Job Description

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. 1. Work with a small team of new product design engineers focused on the design of a new large bore delivery catheter.
2. 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. 3. Provides guidance to product and technology teams.
4. 4. Assesses the feasibility and soundness of alternative engineering processes, products, or equipment.
5. 5. Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
6. 6. Develop and coach others on engineering documentation.
7. 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+ yearsof 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

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.