Principal Engineer-Disposables R&D (hybrid)

Vantive•Plymouth, MN

8d•$108,000 - $148,500•Hybrid

About The Position

Vantive is a vital organ therapy company focused on extending lives and expanding possibilities for patients and care teams. The Principal Engineer-Disposables R&D leads the design and development of product changes for disposable medical devices within new product development engineering. The role serves as a technical expert for design change programs and leads engineering projects with minimal guidance, coordinating R&D work with global cross-functional stakeholders. The position requires advanced knowledge of plastics materials and processing, medical-device design controls, quality systems, and risk management. Vantive’s flexible workplace policy requires a minimum of three days per week onsite. The estimated base salary is $108,000 to $148,500 annually; the position may also be eligible for discretionary bonuses and/or long-term incentives.

Requirements

Bachelor’s degree in Mechanical, Plastics, Biomedical Engineering, or a related field.
5–8+ years of related experience in Class II or Class III disposable medical product development.
Advanced knowledge of plastics materials and processes, including injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
Working knowledge of CAD design and PDM enterprise software.
Working knowledge of ANSI/AAMI/ISO 14971, Medical Devices—Application of Risk Management to Medical Devices.
Ability to identify technical risks, develop and execute mitigations, and guide teams in removing or avoiding roadblocks.
Initiative, learning aptitude, innovation, and ability to implement best practices and continuous improvements.
Ability to manage multiple priorities and work in a self-directed, resourceful manner.
Strong interpersonal, communication, collaboration, and influencing skills.
Ability to read, write, and comprehend English.

Nice To Haves

Master’s degree preferred.
Experience with CAD/PDM tools such as Creo or Solidworks.

Responsibilities

Schedule, budget, and lead engineering projects with minimal guidance.
Serve as the technical expert for design change programs, including new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation.
Identify, investigate, and solve complex engineering problems using risk-based and customer-focused approaches and engineering tools.
Lead the creation and maintenance of design history files.
Coordinate and communicate R&D efforts in collaboration with global cross-functional stakeholders.
Follow design control procedures, general safety rules, company policies and procedures, and FDA and international regulations and guidance.
May supervise engineers and/or technicians.
Contribute to Vantive intellectual property through invention disclosures and patent applications.
Train and coach others using technical expertise.

Benefits

Medical, dental, and vision coverage starting on day one.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Vantive 401(k) retirement savings plan and Aon Pooled Employer Plan resources.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence.
Paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program (EAP).
Childcare benefits.
The position may be eligible for discretionary bonuses and/or long-term incentives.