Senior Disposable Medical Devices R&D Engineer

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

Job summary

Vantive seeks an engineer to support or lead development of new disposable medical devices with global cross-functional teams. You will translate user needs into precise product requirements and drive design through a stage/gate NPD process.

Responsibilities include identifying and solving engineering problems using DFSS, design controls, CAD tools (Creo/SolidWorks), and risk management per ISO 14971. You will build prototypes, run validations, and ensure regulatory compliance.

Qualifications

• BS in Mechanical/Plastics/Biomedical Engineering or related field.
• 3–5+ years in Class II/III disposables medical product development.
• DFSS training or certification preferred.
• Operating within a stage/gate based NPD process.
• Knowledge of plastics processing (injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization).
• CAD and PDM software (Creo, SolidWorks).
• FDA Design Controls and ISO 13485 knowledge.
• ANSI/AAMI/ISO 14971 medical device risk management knowledge.
• Takes initiative with learning, innovation and continuous improvement.
• Strong collaboration and communication skills.
• Attention to detail and ability to manage multiple priorities.
• Excellent reading/writing in English.

Responsibilities

• Support or lead projects with global cross-functional teams for disposable products development.
• Translate user needs into product requirements.
• Investigate and solve engineering problems using risk-based approaches and tools (dFMEA, HF, CAD).
• Create and maintain design history file documentation.
• Develop and execute test methods, validations, and verifications.
• Build prototypes and tooling; operate machine tools as needed.
• Adhere to design controls, safety rules, policies, FDA/ISO regulations.

Skills

DFSS training

Stage/gate NPD

CAD

PDM software

FDA Design Controls

ISO 13485

ANSI/AAMI/ISO 14971

English reading/writing

Initiative & learning

Communication skills

Attention to detail

Education

BS in Mechanical/Plastics/Biomedical Engineering

MS preferred

Tools

Creo

SolidWorks

Job description

Vantive seeks an engineer to support or lead development of new disposable medical devices with global cross-functional teams. You will translate user needs into precise product requirements and drive design through a stage/gate NPD process.

Responsibilities include identifying and solving engineering problems using DFSS, design controls, CAD tools (Creo/SolidWorks), and risk management per ISO 14971. You will build prototypes, run validations, and ensure regulatory compliance.