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Principal Engineer
3 months ago
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
our Role:Leads design and development of product changes within new product development 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. new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
- Identify, investigate, and solve complex engineering problems applying 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 team members.
- Enforce to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
- 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 implement mitigations and provide team direction on how to remove or avoid roadblocks.
- Takes initiative with a high interest in learning, innovation, and implementing standard processes 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.
- 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.
Baxter 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. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, 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 $104,000 to $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter 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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.