Sr. Principal Compliance Engineer
3 weeks 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.
The Renal Center of Excellence (CoE) Compliance Engineering team is a part of the R&D organization that supports the Renal Care business unit. Within the team we provide compliance engineering activities in all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue Baxter’s mission to save and sustain lives.
Baxter is a global company with R&D sites at multiple locations in the world; competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites. Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities.
In this role, the Sr. Principal Compliance Engineer will be responsible for leading the efforts in the coordination and management of standards compliance activities for assigned programs. This includes working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products. This position requires candidates to maintain their knowledge of current standards and developing or changing standards that affect Kidney Care products.
Essential Duties and Responsibilities:
Coordination and management of product safety and wireless compliance activities for assigned programs, working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products.
Partner with design engineers to develop product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans, participate in design and development activities and partner to resolve product certification, wireless and product safety issues.
Develop and drive product certification strategy to facilitate market access in the intended market(s) and lead compliance issues throughout the lifecycle of the product.
In partnership with Baxter’s Environmental Health and Safety team, support efforts to comply with environmental regulations (e.g. RoHS, REACH, WEEE).
Facilitate and coordinate input from multiple cross-functional partners including Regulatory team, program management, R&D teams, manufacturing sites and service locations to develop and drive comprehensive product certification and compliance strategies, develop and maintain therapy area compliance roadmaps and dashboards.
Keep abreast of changes to product standards, wireless standards and regulations affecting medical and wireless products.
Ensure that all in-house compliance test equipment complies with the test requirements specified in compliance standards and regulations.
Schedule compliance testing for products at onsite test facility and at external test laboratories.
Manage and plan wireless host testing on products that have implemented wireless technologies.
Support regulatory submissions and wireless approvals (e.g. EU, UL, Canada, Korea, Japan, Australia/New Zealand).
Prepare standards test reports and other documentation in accordance with applicable regulations.
Serve in a consultative capacity on product safety & regulatory compliance and product qualification activities to ensure compliance with national and international product safety regulatory requirements in the company’s product designs.
Provide technical direction and communication across engineering, contracts, and legal to ensure understanding, cooperation and coordination.
Qualifications:
Knowledge of worldwide medical device requirements. Deep understanding of the US, European Union, Canadian, Australian, Japan, Brazil and China markets.
Experience with IEC 60601-1 family of standards and wireless regulations preferred.
Excellent understanding of EMC and wireless test equipment and testing method in accordance with domestic and international standards.
Knowledge of EMC and wireless regulations and certification procedures applicable to Medical Devices sold worldwide including testing documentation, certification requirements and procedures (i.e.IEC60601-1-2, CISPR 11, FCC, RED etc.).
Ability to perform diagnostics and correct EMC failures in conjunction with design engineers.
Strong electronics background is preferred.
Experience in Requirements Management, Configuration Management, Defect Tracking and Traceability Experience with EMC design tools, automated EMC testing tools, electronic test equipment (oscilloscopes, logic analyzers).
National/international product safety standards knowledge required
Excellent written, oral and interpersonal skills
Must be proficient at time management and multitasking
Knowledge of FDA's guidance on design controls and software validation (IEC 62304), as well as ANSI/IEEE standards for EMC and wireless engineering
Demonstrated experience interfacing with regulatory agencies, conformity assessment bodies (UL, Intertek, TuV,CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).
Demonstrated strong analytical and problem-solving skills
Success in working with multifunctional, global teams.
Strong team player, able to meet deadlines and handle changing priorities
Experience in resolving complex technical problems using strong analytical skills
Success in delivering results on technical challenges including investigative and problem-solving skills
Education and Work Experience:
BS or MS in engineering
10+years of experience in compliance engineering
Demonstrated experience working with certification bodies (UL, TUV, Intertek CSA etc.)
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.
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