Job Description

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\xe2\x80\x94where your purpose accelerates our mission.

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\xe2\x80\x99s 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\xe2\x80\x99s 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
• Excellent verbal and written communication skills
• Success in working with multifunctional, global teams.

• BS or MS in engineering
• 5+years of experience in compliance engineering
• Demonstrated experience working with certification bodies (UL, TUV, Intertek CSA etc.)

Reasonable Accommodations

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.

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