Principal Engineer

About the role

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

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.

Requirements

• 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.

Qualifications

• 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.

Skills

• 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.

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.
• Financial and retirement benefits: Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan.
• The Aon PEP provides retirement resources, investment options, financial education, and resources to support retirement goals.
• Flexible Spending Accounts.
• Educational assistance programs.
• Time‑off benefits: paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and