Senior Principal Engineer, Product Risk Management Owner

3 weeks 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
Responsible for leading all of the activities associated with the Risk Management of a platform of products with projects in multiple stages of the product lifecycle from new product development to post-market
surveillance.

What you'll be doing

  • Provides strategy for continuous improvement of the risk management file and conducts ongoing risk analysis and identification of required risk mitigations to ensure a safe, effective product.

  • Responsible for identifying risks and helping define requirements and verification validation testing to mitigate risk

  • Drive completion of Risk Management activities towards design transfer and successful commercialization of new products.

  • Provides leadership and subject matter expertise to risk engineers and to product development teams to ensure Risk Management principles are applied throughout the development cycle.

  • Creates and approves Design History File deliverables associated with Risk Management.

  • Assesses and improves the Risk Management process across product platforms collaborating across products to align strategy and process improvements.

  • Facilitate an improved understanding of the interrelationship between Risk and Reliability.

  • Expedite, manage, and coordinate interrelated Risk Management activities across functions, within the constraints of human and financial resources and changing priorities.

  • Participate in identifying and planning tasks, activities, and resourcing needs related to Risk Management.

  • Collaborates with Engineering, Manufacturing, and Service organizations in the development of design FMEA, Process FMEAs, and roll-up into Risk Management files.

  • Working knowledge of FMEAs and standards applicable to Reliability Engineering (e.g IEC 60812).

  • Recognizes strategy, evaluates risks, recommends actions, and develops contingencies to address various scenarios. Able to analyze risk/tradeoffs and make recommendations of the appropriate path forward.

  • Motivates and successfully influences stakeholders and cross-functional team members within the project.

What you'll bring

  • BS/MS in Engineering with 10 or more years experience in practical Electromechanical Medical Device Design or Medical Systems Experience.

  • 5 or more years of experience with risk management for complex design or systems using formal risk management methodologies

  • Able to lead complex projects and has led the risk management activities of multiple programs.

  • Experience with risk management throughout the product development lifecycle.

  • Six Sigma Green belt or Balack Belt (DFSS) certification preferred

  • Experience working with Agile program methodologies

  • Knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.).

  • Understanding and application of the standards related to Risk Management and Reliability: (e.g., ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633, etc.)

  • Experience developing requirements based on risk for products and/or process

  • Strong experience in Requirements Management, Configuration Management, Defect Tracking and Traceability

  • Experience leading collaboration and problem solving with globally located cross-functional representatives team members

  • Experience in resolving complex technical problems using strong analytical skills

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $120,000 to $165,000 plus an annual incentive bonus. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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 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 .

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