Principal Engineer

About the role

Leads design and development of product changes within sustaining engineering for disposable medical devices.

What You'll Be Doing

• 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.

What You'll Bring

• 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.

Qualifications

• 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.

Pay

Estimated base salary: $104,000 to $156,000 annually. Individual pay based on location, skills, expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and/or long-term incentive.

Schedule

Minimum of 3 days a week onsite.

Benefits

• Medical, dental and vision coverage starting on day one.
• Basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Aon Pooled Employer Plan (Aon PEP) 401(k) retirement savings plan with robust investment options, financial education, and retirement resources.
• 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 and paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.