Senior Principal Engineer — Medical Devices & Design Change

Vantive; Minneapolis (MN); Hybrid; USD 104,000 - 156,000; Full time

Benefits offered by this job

Medical, dental and vision coverage (d

Job summary

Vantive, a leading organ therapy company, seeks an experienced engineer to lead design changes for disposable medical devices within sustaining engineering. You will manage projects, coordinate with suppliers, and ensure compliance with FDA design controls and ISO standards.

The role requires a BS in Mechanical, Plastics, Biomedical Engineering or related field with 5+ years in Class II/III disposables development; CAD experience (Creo/SolidWorks); and a collaborative, proactive mindset.

Qualifications

• BS in Mechanical, Plastics, Biomedical Engineering or related field; MS preferred.
• 5+ years in Class II/III disposables medical product development.
• Advanced knowledge of CAD and PDM software.

Responsibilities

• Schedule, budget, and lead engineering projects with minimal guidance.
• Serve as the technical expert for design change programs (e.g. suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
• Identify, investigate, and solve complex engineering problems utilizing risk-based approaches and engineering tools.
• Lead the creation and maintenance of design history files.
• Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
• Adhere to design control procedures, FDA and ISO regulations and guidance.
• May supervise engineers and/or technicians.
• Contribute to Vantive's intellectual property through invention disclosures.

Education

BS in Mechanical, Plastics, Biomedical Engineering or related field

MS preferred

Tools

Creo

SolidWorks

Job description

Vantive, a leading organ therapy company, seeks an experienced engineer to lead design changes for disposable medical devices within sustaining engineering. You will manage projects, coordinate with suppliers, and ensure compliance with FDA design controls and ISO standards.

The role requires a BS in Mechanical, Plastics, Biomedical Engineering or related field with 5+ years in Class II/III disposables development; CAD experience (Creo/SolidWorks); and a collaborative, proactive mindset.