Sr. Engineer - Disposables R&D, 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.

Your Role supports design and development of product changes, within sustaining engineering, for disposable medical devices.

What you’ll be doing:

• Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
• Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
• Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings.
• Develop and execute test method validations, product testing, and verification/validation activities.
• Build prototypes and models. May operate machine tools, design and build basic tooling, test fixtures and assembly equipment.
• Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

What you’ll bring:

• Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
• Working knowledge of CAD and PDM enterprise software (e.g. Creo, Solidworks).
• Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
• Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
• BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
• 3+ years of related experience in Class II or Class III disposables medical product development.
• Design for Six Sigma (DFSS) training or certification preferred.

Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 - $121,000 annually. Individual pay is based on location, skills and expertise, experience, and other relevant factors.

US Benefits at Vantive:

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.

Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), Vantive's 401(k) retirement savings plan, to help you prepare for your future. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as 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.

Join us and enjoy the competitive compensation and benefits we offer to our employees.

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.

Reasonable Accommodation: Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally.