Lead, Disposables Medical Device R&D

Vantive; Minneapolis (MN); On-site; USD 108,000 - 149,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401(k) retirement plan

Paid holidays

Paid time off 20–35 days

Disability insurance

Commuting benefits

Employee discount program

Employee Assistance Program (EAP)

Job summary

Vantive is seeking an experienced mechanical/biomedical engineer to lead design and development of disposable medical devices in our NPD program. You’ll schedule projects, guide design changes, and work with global teams to ensure risk management and regulatory compliance.

You will mentor engineers, maintain design history files, and contribute to IP while advancing packaging, labeling, and manufacturing interfaces in a fast-paced environment.

Qualifications

• BS in Mechanical, Plastics, Biomedical Engineering or related field.
• 5–8+ years in Class II/III disposables product development.
• Proficient in CAD (Creo, SolidWorks) and PDM systems.
• Knowledge of FDA Design Controls and ISO 13485.
• Experience with risk management tools (e.g., dFMEA, HF engineering).

Responsibilities

• Schedule and lead engineering projects with minimal guidance.
• Serve as technical expert for design change programs (new products, materials, labeling, CAPA/NCR, cost reduction).
• Identify, investigate, 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 global cross-functional stakeholders.
• Adhere to design control procedures and FDA/ISO regulations.
• May supervise engineers and/or technicians.
• Contribute to intellectual property through disclosures and patents.

Skills

Creative problem solving

Self-directed

Strong communication

Collaboration

Education

BS in Mechanical/Plastics/Biomedical Eng

MS preferred

Tools

Creo

SolidWorks

CAD/PDM

Job description

Vantive is seeking an experienced mechanical/biomedical engineer to lead design and development of disposable medical devices in our NPD program. You’ll schedule projects, guide design changes, and work with global teams to ensure risk management and regulatory compliance.

You will mentor engineers, maintain design history files, and contribute to IP while advancing packaging, labeling, and manufacturing interfaces in a fast-paced environment.