Vantive · 1 day ago
Principal Engineer
Minneapolis, MN
Full-time
Hybrid
Senior Level, Lead/Staff
$104K/yr - $156K/yr
5+ years expVantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. The Principal Engineer will lead design and development of product changes within sustaining engineering for disposable medical devices, focusing on project management, technical expertise, and collaboration across teams.
Health CareMedicalTherapeuticsWellness
Responsibilities
Schedule, budget, and lead engineering projects with minimal guidance
Serve as the technical expert for design change programs (e.g. suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation)
Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools (e.g. dFMEA, Human Factors Engineering, statistical software, CAD)
Lead the creation and maintenance of design history files
Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders
Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance
May supervise engineers and/or technicians
Contribute to Vantive's intellectual property through invention disclosures and patent applications
Qualification
Required
Leads design and development of product changes within sustaining engineering for disposable medical devices
Schedule, budget, and lead engineering projects with minimal guidance
Serve as the technical expert for design change programs (e.g. suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation)
Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools (e.g. dFMEA, Human Factors Engineering, statistical software, CAD)
Lead the creation and maintenance of design history files
Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders
Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance
May supervise engineers and/or technicians
Contribute to Vantive's intellectual property through invention disclosures and patent applications
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 (e.g. Creo, Solidworks)
Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices
Creative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks
Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements
Ability to train and coach others from technical expertise
BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred
5+ years of related experience in Class II or Class III disposables medical product development
Benefits
Medical, dental and vision coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
401(k) retirement savings 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
Company
Vantive
Vantive US Healthcare LLC specializes in kidney care and organ support therapies with digital solutions.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-08-13Acquired
Recent News
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