Sr. Principal Engineer, Design Assurance
BAXTER Genoa , NY
30+ DAYS AGO
Full Time
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
Your Role at Baxter
This is where your creativity addresses challenges
In this position, you will lead and support Product Development and Lifecycle Management deliverables review and approval. You will support Internal and External Audits, and provide process consultancy to the R&D teams in Design Controls, CAPA and Risk Management Files.
Your Team at Baxter
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
What you'll be doing
- Represent the Product Quality function in various roles such as product support and lifecycle management.
- Assist in decision making for process improvement efforts.
- Responsible for Quality Assurance of the Product Development and Lifecycle Management process.
- Responsible for the compliance and approval of PDLM records to Baxter procedures throughout the product lifecycle.
- Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
- Support risk management activities for sustaining and continuing engineering projects.
- Support post market activities such as complaint investigation, complaint trending, CAPA, and FA processes.
- Support global manufacturing facilities and associated manufacturing and supplier changes.
- Preside as key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries.
- Review and approve specifications, procedures, qualification/verification/validation protocols and reports, test cases and related documentation.
- Conduct internal audit and provide feedback to continual improvement.
- Ensure compliance of and maintain product Design History Files. Perform DHF audits for peer projects.
- Review intended use validation for non-product software and tools used in the development process.
- Mentor engineering team members in the application of life cycle management processes.
- Influential in the application of design for reliability and robustness (DfR) tools.
- Effective and timely communications to project stakeholders.
- Embraces accountability for meeting deadlines and making critical decisions.
What you'll bring
- Bachelor of Science in Engineering degree required.
- 8+ years in related Quality or Engineering field in the medical products industry.
- ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred.
- Knowledge of FDA Regulations.
- Proven ability to lead others in project or investigational environments.
- Good technical overview of medical device verification, validation and test automation.
- Understanding of 21 CFR Part 820, ISO 13485, EU MDD / EU MDR.
- Broad working knowledge of Medical Device Software Development Lifecycle and IEC 62304.
- Understanding of requirements for Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation.
- Understanding of design for reliability and robustness (DfR) tools (e.g. Real World Usage Profiles, Weibull, Design of Experiments).
- Understanding of printed circuit board design and assembly.
- Understanding of injection molding, extrusion and hard tooling.
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 $112,000 - $154,000 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.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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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.
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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