Senior Medical Device Engineer — Sustaining & Design

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

Benefits offered by this job

3 days onsite per week

Discretionary bonuses

Long-term incentives

Job summary

Vantive is a vital organ therapy company advancing kidney care with digital solutions and advanced services. This role leads sustaining engineering for disposable medical devices, driving design changes and ensuring regulatory compliance.

The position requires 5+ years in Class II/III device development, FDA Design Controls expertise, and CAD tool proficiency, with collaboration across global teams onsite in Minnesota.

Qualifications

• BS in Mechanical, Plastics, Biomedical Engineering or related field; MS preferred.
• 5+ years of related disposable medical product development experience (Class II/III).
• Experience with design controls and regulatory compliance is essential.

Responsibilities

• Schedule, budget, and lead engineering projects with minimal guidance.
• 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 the creation and maintenance of design history files.
• Coordinate and communicate R&D efforts with global cross-functional stakeholders.

Skills

Advanced knowledge of FDA Design Conc

CAD design (Creo, SolidWorks)

Materials processing (injection mold.,

Risk management (ISO 14971)

Leadership / mentoring

Education

BS in Mechanical, Plastics, Biomedical Eng or related

MS preferred

Tools

Creo

SolidWorks

Job description

Vantive is a vital organ therapy company advancing kidney care with digital solutions and advanced services. This role leads sustaining engineering for disposable medical devices, driving design changes and ensuring regulatory compliance.

The position requires 5+ years in Class II/III device development, FDA Design Controls expertise, and CAD tool proficiency, with collaboration across global teams onsite in Minnesota.