Senior Disposables R&D Engineer – NPD Impact

Vantive; Plymouth (MN); On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

Health, dental, vision coverage

401(k) retirement plan

Paid time off and holidays

Parental leave

Job summary

Vantive, a vital organ therapy innovator, invites a Mechanical/Biomedical Engineer to lead and support disposable medical device development. You will collaborate with global cross-functional teams to translate user needs into rigorous product requirements and maintain design history files.

You will apply DFSS principles, operate within a stage-gate development process, and leverage CAD tools (Creo, SolidWorks) to prototype, test, and refine devices.

Qualifications

• 3–5+ years in Class II/III disposables medical product development.
• DFSS training or certification preferred.
• Experience with stage/gate new product development process.
• Knowledge of plastics processing (injection molding, extrusion, ultrasonic welding, UV/solvent bonding).
• Understanding CAD and PDM tools (e.g., Creo, SolidWorks).
• Familiarity with FDA Design Controls and ISO 13485.

Responsibilities

• Support or lead global projects for disposable products.
• Translate user needs into product requirements.
• Investigate engineering problems using risk-based methods.
• Maintain design history files and reports.
• Develop and execute test method validations and verifications.
• Build prototypes and basic tooling.
• Adhere to design controls and quality/regulatory requirements.

Skills

Medical device development

Cross-functional collaboration

Risk-based testing

Quality mindset

Reading/Writing English

Education

BS in Mechanical, Plastics, Biomedical Engineering or related field

MS preferred

Tools

Creo/SolidWorks

CAD software

FDA Design Controls

ISO 13485

14971 Risk Management

dFMEA

Job description

Vantive, a vital organ therapy innovator, invites a Mechanical/Biomedical Engineer to lead and support disposable medical device development. You will collaborate with global cross-functional teams to translate user needs into rigorous product requirements and maintain design history files.

You will apply DFSS principles, operate within a stage-gate development process, and leverage CAD tools (Creo, SolidWorks) to prototype, test, and refine devices.