Sr. Disposables R&D Engineer — NPD & Medical Devices

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

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Paid time off 20–35 days

Life and disability insurance

Employee assistance program

3 onsite days per week policy

Job summary

Vantive is a vital organ therapy company focused on extending lives through digital solutions and advanced services. The role supports new disposable medical device development within global cross-functional teams.

You will translate user needs into product requirements, perform risk-based problem solving, develop test methods, and maintain design history files while adhering to FDA/ISO standards. A hands-on engineer with CAD skills and DFSS training will thrive in this fast-paced environment.

Qualifications

• BS in Mechanical, Plastics, Biomedical Eng or related field; MS preferred.
• 3–5+ years in Class II/III disposables product development.
• DFSS training or certification preferred.
• Experience with stage/gate NPD processes.
• Knowledge of plastics materials and processing (injection, extrusion, welding).
• CAD and PDM software knowledge (Creo/SolidWorks).
• FDA Design Controls and ISO 13485 knowledge.
• ANSI/AAMI/ISO 14971 awareness in risk management.
• Initiative and continuous improvement mindset.
• Strong collaboration and communication skills.
• Attention to detail; ability to manage multiple priorities.
• Proficient reading/writing English.

Responsibilities

• Support or lead projects with global cross-functional teams for disposable products.
• Develop user needs and translate to product requirements.
• Investigate and solve engineering problems using risk-based approaches and tools (dFMEA, HF, CAD).
• Create and maintain design history files: protocols, reports, specs, labeling, drawings.
• Develop and execute test method validations and product testing activities.
• Build prototypes and operate basic tooling and fixtures; assist assembly tooling.
• Adhere to design controls, safety rules, and FDA/ISO guidance.

Skills

Medical device development

Cross-functional collaboration

DFSS training or certification

Stage/gate NPD process

English reading/writing

Problem solving in risk-based context

Education

Bachelor's in Mechanical/Plastics/Biomedical Eng

MS preferred

Tools

Creo

SolidWorks

PDM software

Job description

Vantive is a vital organ therapy company focused on extending lives through digital solutions and advanced services. The role supports new disposable medical device development within global cross-functional teams.

You will translate user needs into product requirements, perform risk-based problem solving, develop test methods, and maintain design history files while adhering to FDA/ISO standards. A hands-on engineer with CAD skills and DFSS training will thrive in this fast-paced environment.