Senior R&D Engineer - Medical Devices (Onsite)

Pharmavise Corporation; Osseo (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Pharmavise Corporation is seeking a Senior R&D Engineer for a medical device program onsite at Arbor Lakes, MN. You will independently drive development work on a new large bore catheter design, support a 510(k) submission, and mentor teammates through technical documentation and design control practices.

Ideal candidates have a minimum of a bachelor’s in engineering, 5+ years of experience in regulated medical devices, and strong CAD, tolerance analysis, and quality tool usage.

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering or related technical discipline.
• 5+ years of experience in design assurance, new product development or related medical device/regulatory industry.
• Experience with design controls, print packages, tolerance analysis and GD&T.
• Self-motivated with problem-solving mindset and bias for action.
• Strong verbal and written communication skills.
• Demonstrated use of quality tools/methodologies.
• Ability to work effectively in mixed onsite + remote environment.
• Proven experience creating detailed technical documents.

Responsibilities

• Work with a small team of new product design engineers on a large bore delivery catheter.
• Independently develop deliverables for a 510k regulatory submission (CAD design, print packages, specs, BOM, mappings, DFMEAs, tolerance analyses).
• Provide guidance to product and technology teams.
• Assess feasibility and soundness of alternative processes, products or equipment.
• Coordinate, manage and document project goals and progress, recommending revisions.
• Develop and coach others on engineering documentation.
• Demonstrate PDP/TPD knowledge through coaching and high-quality deliverables.

Skills

Design controls

GD&T

Tolerance analysis

Print packages

Quality tools/methodologies

Communication

Collaboration

Problem solving

Education

Bachelor’s degree in mechanical or biomedical engineering

Tools

CAD

Job description

Pharmavise Corporation is seeking a Senior R&D Engineer for a medical device program onsite at Arbor Lakes, MN. You will independently drive development work on a new large bore catheter design, support a 510(k) submission, and mentor teammates through technical documentation and design control practices.

Ideal candidates have a minimum of a bachelor’s in engineering, 5+ years of experience in regulated medical devices, and strong CAD, tolerance analysis, and quality tool usage.