**Are you looking for a career that matters?**
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Apply a solid understanding of theories/practices in Risk Management toward the development of new or enhanced products or processes. Support the advancement of Risk and Reliability competencies and execution across the Device Engineering organization.
**Essential Duties and Responsibilities**
+ Plan, schedule, and lead project assignments using appropriate engineering techniques, processes, and methods with minimal guidance.
+ Identify and define risk and reliability related requirements from applicable product standards (collateral and particular).
+ Provide leadership and coaching to design teams in Risk process execution using relevant methodologies, tools, and techniques.
+ Lead and coach design teams in the development/maintenance of Risk planning and deliverables aligned with Baxter Global Risk Management procedures.
+ Collaborate with cross-functional resources (e.g. hardware, clinical, human factors, etc.) involved in Risk Management and Reliability process activities.
+ Support sustaining teams in investigation of Risk and Reliability issues.
+ Lead teams through credibility and influence.
+ 12+ years of hands-on experience in Product Design, and fluent in full life-cycle product development methods/activities, preferably in a regulated industry.
+ Must possess engineering knowledge and experience in relevant electromechanical disciplines and design, preferably Medical Devices.
+ Working knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.).
+ Solid understanding and application of the standards related to Risk Management: (e.g., ISO 13485, ISO 14971, IEC 61025, IEC 62366, IEC 60601, etc.).
+ Demonstrated experience in creation of typical failure analysis deliverables (Hazards Analysis, FMEAs, FTAs, etc.).
+ Understanding and experience in performing root-cause analysis in investigations
+ Expertise and fluency in Excel, Minitab, Doors, and other Requirements Management & Risk tools.
+ Strong critical thinking skills.
+ Requires strong organization and polished communication skills (both written and oral), with the ability to interface with both technical and non-technical personnel throughout the organization.
+ Able to work independently or with a cross-functional team in a fast-paced environment.
+ Able to lead multiple projects and work across organization boundaries.
+ B.S.in Mechanical Engineering, Electrical Engineering, or related field and 5 – 8-year related experience.
**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 at http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the law – Poster Supplement at http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy at https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
Our products and therapies touch the lives of millions of people around the world every day, which is why we are focused on transformative innovations that bring smarter, more personalized care to all of us. For 87 years and counting, we have been at the critical intersection where the ideas that save and sustain lives meet the providers who make it all happen. And now, we are determined to realize our boldest opportunities to transform global healthcare for years to come.