R&D Engineer - Medical Disposables (Entry Level)

Vantive; Plymouth (MN); On-site; USD 76,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Dental and vision benefits

401(k) retirement plan

Paid time off 20–35 days

Job summary

Vantive is seeking a design-focused engineer to support product changes in sustaining engineering and new product development for disposable medical devices. You will identify and solve engineering problems using dFMEA, Human Factors, CAD tools, and risk-based approaches.

You will create and maintain design history files, validate methods, and build prototypes while following design controls and regulatory guidance to ensure patient safety and product quality.

Qualifications

• BS in Mechanical, Plastics, Biomedical Engineering or related field; MS preferred.
• 0–2+ years in Class II/III disposable medical product development.
• DFSS training or certification preferred.
• Understanding of plastics processing (injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization).
• Working knowledge of CAD and PDM software (e.g., Creo, SolidWorks).
• Understanding of FDA Design Controls and ISO 13485 Quality Management Systems.
• Understanding of ANSI/AAMI/ISO 14971 Medical Devices – Risk Management.

Responsibilities

• Support design changes and product development in sustaining and new product development for disposable medical devices.
• Use risk-based and customer-focused approaches to solve engineering problems (e.g., dFMEA, Human Factors, CAD, statistics).
• Create, modify, and maintain DHF documentation (protocols, reports, design specs, labeling, drawings).
• Support test method validations, product testing, and verification/validation activities.
• Build prototypes and models; operate tools and basic tooling/test fixtures.
• Adhere to design controls, safety rules, and FDA/ISO guidance.

Skills

Mechanical/Biomedical Eng

0–2 years experience

DFSS training

CAD design

FDA Design Controls

ISO 13485 Knowledge

Risk-based engineering

Documentation & DHF

Verification & Validation

Problem solving

Education

BS in Mechanical, Plastics, Biomedical Eng

MS preferred

Tools

Creo

SolidWorks

Job description

Vantive is seeking a design-focused engineer to support product changes in sustaining engineering and new product development for disposable medical devices. You will identify and solve engineering problems using dFMEA, Human Factors, CAD tools, and risk-based approaches.

You will create and maintain design history files, validate methods, and build prototypes while following design controls and regulatory guidance to ensure patient safety and product quality.