Senior R&D Engineer, Medical Devices (Onsite)

Pharmavise Corporation; Osseo (MN); Sur place; USD 110 000 - 160 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Communication

Problem solving

Quality tools

Collaboration

Technical docs

GD&T

Change management

Regulatory knowledge

Formation

Bachelor's degree in mechanical/biomedical engineering

Outils

CAD

DFMEA

Tolerance analysis

Description du poste

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