Principal Engineer – Medical Devices (Disposables)

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

Benefits offered by this job

Health insurance

401(k) retirement plan

Paid time off

Paid holidays

Educational assistance

Commuting benefits

Employee discount program

Job summary

Vantive, a vital organ therapy company, seeks an engineer to lead design changes within sustaining engineering for disposable medical devices. You will drive projects, serve as a technical expert on design change programs, and collaborate with global R&D teams to address complex problems using risk-based methods and CAD tools.

You will ensure compliance with FDA Design Controls and ISO 13485, mentor junior staff, and contribute to IP through disclosures and patent work.

Qualifications

• BS in Mechanical, Plastics, Biomedical Engineering or related field; MS preferred.
• 5+ years in Class II or Class III disposables medical product development.
• Experience with FDA Design Controls and ISO 13485 quality systems.

Responsibilities

• Lead design and development projects within sustaining engineering for disposable medical devices.
• Serve as the technical expert for design change programs (suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
• Identify, investigate, and solve complex engineering problems using risk-based and customer-focused approaches and engineering tools (e.g., dFMEA, Human Factors, CAD).
• Lead creation and maintenance of design history files.
• Coordinate and communicate R&D efforts with global cross-functional stakeholders.
• Adhere to design control procedures and regulatory guidelines (FDA, ISO).
• May supervise engineers and/or technicians.
• Contribute to Vantive’s intellectual property through disclosures and patents.

Skills

Injection molding

FDA Design Controls

CAD: Creo/SolidWorks

Risk management

Process optimization

Leadership

Education

BS in Mechanical/Plastics/Biomedical Eng

MS preferred

Tools

Creo

SolidWorks

PDM

Job description

Vantive, a vital organ therapy company, seeks an engineer to lead design changes within sustaining engineering for disposable medical devices. You will drive projects, serve as a technical expert on design change programs, and collaborate with global R&D teams to address complex problems using risk-based methods and CAD tools.

You will ensure compliance with FDA Design Controls and ISO 13485, mentor junior staff, and contribute to IP through disclosures and patent work.