Principal Engineer-Disposables R&D (hybrid)

Vantive US Healthcare USA•Plymouth, MN

7d•Hybrid

About The Position

Vantive is hiring a Principal Engineer to lead design and development of product changes for disposable medical devices within new product development engineering. The role leads engineering projects and serves as the technical expert for design change programs involving products, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation. It identifies and solves complex engineering problems using risk-based and customer-focused approaches, coordinates R&D work with global cross-functional stakeholders, and supports design control and regulatory compliance. The position may supervise engineers or technicians and contribute to Vantive intellectual property through invention disclosures and patent applications. The position follows Vantive’s flexible workplace policy, which requires at least three days per week onsite. The estimated annual base salary is $108,000 to $148,500; the position may also be eligible for discretionary bonuses and/or long-term incentives. Eligible employees receive comprehensive compensation and benefits, including health and well-being, financial and retirement, and time-off benefits.

Requirements

BS 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 processing, such as 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, such as Creo or Solidworks.
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 provide team direction to remove or avoid roadblocks.
Initiative and aptitude for learning, innovation, implementing best practices, and continuous improvement.
Ability to train and coach others using technical expertise.
Self-directed, resourceful, and able to manage multiple priorities.
Strong interpersonal, communication, collaboration, and influencing skills.
Ability to read, write, and comprehend English.

Nice To Haves

MS degree preferred.

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 such as dFMEA, Human Factors Engineering, statistical software, and CAD.
Lead the creation and maintenance of design history files.
Coordinate and communicate R&D efforts in collaboration with global cross-functional stakeholders.
Adhere to 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.

Benefits

Medical, dental, and vision coverage starting on day one for eligible roles.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
401(k) retirement savings plan through the Aon Pooled Employer Plan.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays.
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.
Position may be eligible for discretionary bonuses and/or long-term incentives.