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Principal Engineer

4 months ago

Plymouth, United States Baxter Full time

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.

Your Role:

This role is aligned within Kidney care Solutions and the Containers Team working with the Sr. Manager, Solutions and Containers team in the USA. As part of the Product Sustenance and lifecycle management team you will play a key role in defining, organizing, planning and leading global multi-functional projects related to all the modalities of Kidney care (PD, HD and Acute). Propose options and develop action plans for problem-solving, product and process improvements You will also have an opportunity to work on new product development projects and innovative technologies supporting improving our products, therapies and patient outcomes.

What You'll Be Doing:

  • Establish, maintain and update technical & design documentation according to Good Documentation practices. Propose options and develop action plans for problem-solving, product and process inventions and improvements

  • Support changes related to the on-market products through change control management

  • Support Product lifecycle management and Sustenance organization in the area of medical devices and drug products

  • Active participation in the audits related to FDA and other key regulatory agencies as the role requires

  • Anticipate risks/challenges and willingness to help lead ambiguity

What You'll Bring:

  • Masters in Pharmaceutics, Material Science, Polymer Chemistry, Polymer Engineering, Chemical Engineering, Biology, Biosciences and Biomedical engineering.

  • Ph.D preferred

  • Minimum of 3 years of diverse industrial experience post Ph.D and 5 years post Masters in the given technical domains

  • Knowledgeable with ICH, FDA, relevant cGxPs, ISO, and quality systems associated with pharmaceutical and medical devices development

  • Understands the implications of raw material change in pharmaceutical and medical devices industries (product impact, process impact, regulatory implications, end user, sterilization etc.)

  • Proven track record to create results within budget, timeline, and product/project work you're doing

  • Broad understanding of the overall product and therapy along with deep technical expertise in one or more fields related to drugs and medical devices

  • Sound knowledge of structure property relationships of polymers/materials

  • Prior experience with the new materials development, characterization and process optimizations

  • Exposure to material characterization tools, extractables and leachables and REACH complaint materials for drug products/medical devices

  • Knowledge of manufacturing processes and process optimizations for drug products/medical devices preferably in Parentals/combination devices space

  • Possesses an agile attitude

  • Strong technical leadership and prior experience of leading multi-functional projects at a global front

  • Expertise in design Control documentation and medical writing

  • Experience with Statistics and Six Sigma tools

  • Experience with Trackwise, Digital Twin and other quality tools of interest

  • Experience with handling NCR, CAPA and other quality management systems

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 $143,00 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 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.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

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