Senior Engineer, Disposable Medical Devices R&D

Vantive; Minneapolis (MN); Hybrid; USD 88,000 - 121,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

Paid time off 20–35 days

Flexible Spending Accounts

Parental leave

Disability insurance

Job summary

Vantive is advancing vital organ therapies and is seeking an engineer to support development of disposable medical devices. You will work with global cross-functional teams to translate user needs into product requirements, manage design history files, and lead verification/validation activities, ensuring compliance with FDA Design Controls and ISO 13485.

The role requires 3–5+ years in Class II/III disposables and strong CAD skills. Minimum BS in engineering is required; MS preferred.

Qualifications

• BS in Mechanical, Plastics, Biomedical Engineering or related field.
• MS degree preferred for advanced candidates.
• Experience in Class II/III disposable medical product development is required.

Responsibilities

• Support or lead projects with global cross-functional teams for disposable products.
• Develop user needs and translate to product requirements.
• Identify, investigate and solve engineering problems using risk-based approaches and tools (e.g., dFMEA, Human Factors, CAD).
• Create, modify and maintain design history file documentation (protocols, reports, specs, labeling, drawings).
• Develop and execute test method validations, product testing and verification/validation activities.
• Build prototypes and basic tooling; operate machine tools and test fixtures.
• Adhere to design controls, safety rules, policies and FDA/ISO guidance.

Skills

Cross-functional collaboration

Verbal communication

Written communication

English proficiency

Education

Bachelor's degree in Mechanical, Plastics, Biomedical Engineering

Master's degree preferred

Tools

Creo

SolidWorks

Job description

Vantive is advancing vital organ therapies and is seeking an engineer to support development of disposable medical devices. You will work with global cross-functional teams to translate user needs into product requirements, manage design history files, and lead verification/validation activities, ensuring compliance with FDA Design Controls and ISO 13485.

The role requires 3–5+ years in Class II/III disposables and strong CAD skills. Minimum BS in engineering is required; MS preferred.