Principal Engineer

About the role

Vantive is seeking a Product Change Engineer to lead design and development projects within sustaining engineering for disposable medical devices. The ideal candidate will have advanced knowledge of plastics materials and processing, FDA Design Controls, and ISO 13485 Quality Management Systems.

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).
• Create and maintain design history files.
• Collaborate 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

• 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.

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.

Skills

• Advanced Molding and Extrusion techniques (Learning / Doing (1))
• Automation, reliability & smart manufacturing (Applying / Overseeing (2))
• Critical Systems (Applying / Overseeing (2))
• Data Analysis & Analytics (Applying / Overseeing (2))
• Digitalization & Systems Engineering (Applying / Overseeing (2))
• First Principles Thinking (Applying / Overseeing (2))
• Lean & six sigma process knowledge (Applying / Overseeing (2))
• Modeling & Simulation (Leading / Driving (4))
• Operational Quality Assurance (Applying / Overseeing (2))
• Process Automation (Applying / Overseeing (2))
• Product / Project Management (Applying / Overseeing (2))
• Smart Operations / Industry 4.0 (Learning / Doing (1))
• Software Integration (API, Data Pipelines) (Not Applicable (0))

Benefits

• Comprehensive compensation and benefits packages including medical, dental, and vision coverage, life, accident, short-term, and long-term disability insurance, and business travel accident insurance.
• 401(k) retirement savings plan.
• Flexible Spending Accounts.
• Time-off benefits such as paid holidays, paid time off, family and medical leaves of absence, and paid parental leave.
• Additional benefits including commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

Pay

The estimated base salary for this position is $104,000 to $156,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors.

Schedule

Vantive offers a flexible workplace policy with a minimum of 3 days a week onsite.

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.