Principal Engineer — Medical Device Design & R&D

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

Benefits offered by this job

Onsite 3 days a week

Competitive compensation & benefits

Job summary

Vantive, a medical device company focused on vital organ therapies, seeks a design engineering leader to drive product changes in sustaining engineering for disposable devices. You will manage projects, serve as the technical expert for design changes, and ensure regulatory compliance.

The role requires advanced plastics knowledge, CAD proficiency (Creo/SolidWorks), and strong risk management. Onsite policy supports 3 days per week in the workplace with competitive compensation.

Qualifications

• BS in Mechanical, Plastics, Biomedical Engineering or related field; MS preferred.
• Experience in Class II/III disposables medical product development (5+ years).
• Strong knowledge of CAD and PDM tools; familiarity with design controls and risk management.

Responsibilities

• Lead design and development of product changes within sustaining engineering for disposables.
• Schedule, budget, and lead engineering projects with minimal guidance.
• Serve as technical expert for design change programs (suppliers, materials, labeling, CAPA/NCR, cost reduction).
• Identify and solve complex engineering problems using risk-based and customer-focused approaches.
• Lead creation and maintenance of design history files; coordinate R&D efforts with cross-functional teams.
• Adhere to design control procedures and regulatory guidance; may supervise engineers/technicians.

Skills

Advanced plastics knowledge

FDA Design Controls

CAD (Creo)

CAD (SolidWorks)

Risk Management

Project leadership

Mentoring/training

Education

B.S. in Mechanical/Plastics/Biomedical Engineering

MS preferred

Tools

Creo

SolidWorks

PDM

Job description

Vantive, a medical device company focused on vital organ therapies, seeks a design engineering leader to drive product changes in sustaining engineering for disposable devices. You will manage projects, serve as the technical expert for design changes, and ensure regulatory compliance.

The role requires advanced plastics knowledge, CAD proficiency (Creo/SolidWorks), and strong risk management. Onsite policy supports 3 days per week in the workplace with competitive compensation.