Principal Engineer, R&D Disposables Sustaining

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies.

Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

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., new products, 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.
• May contribute to Vantive's intellectual property through invention disclosures and patent applications.

• BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
• 5 – 8+ years of related experience in Class II or Class III disposables 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 (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.
• Self-directed, resourceful, and able to manage multiple priorities.
• Strong interpersonal, communication, collaboration and influencing skills.
• Ability to read, write and comprehend English.

Vantive is committed to supporting flexibility in the workplace, offering a minimum of three days onsite per week to foster in-person collaboration.

The estimated base salary for this position ranges from $108,000 to $135,000 annually. This range is intended to reflect an anticipated salary range for the role, and may vary by location, skills, experience, and other relevant factors. The position may also be eligible for discretionary bonuses. Compensation may be adjusted above or below the range based on market data and other factors.

Additional benefits include comprehensive medical, dental and vision coverage starting day one; basic life, accident, short‑term and long‑term disability, and business travel accident insurance; a 401(k) retirement savings plan with Aon Pooled Employer Plan (Aon PEP) and robust investment options;
Flexible Spending Accounts; educational assistance programs; paid holidays; paid time off ranging from 20 to 35 days based on length of service; family and…