Sr Compliance Systems Engineer

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
Join Baxter in our mission to save and sustain lives by developing Infusion Systems products. As a Sr Compliance Engineer, your responsibilities will include, ensuring our products are designed to meet regulatory standards, ensuring compliance requirements are properly cascaded to subsystems and risks mitigated by working with talented engineers and partnering with certification agencies to certify our products.

What You'll be doing

• Ensures Infusion Systems hardware solutions comply with applicable standards.
• Collaborate with design engineers to develop product requirements that comply with standards and regulations for intended global markets.
• Cascade system compliance requirements to subsystem requirements to ensure overall design for compliance.
• Assist in developing Compliance Plans, participate in design and development activities (Technical Reviews and Design Reviews) and resolve product certification, compliance and safety issues.
• Assist in develop product certification strategy and resolve compliance issues for complex medical devices.
• Ensures compliance with product related environmental regulations (e.g. REACH, RoHS).
• Keep abreast of changes to product standards and regulations affecting medical products.
• Work with Verification team to review compliance testing plans to ensure compliance to recognized standards and test methods.
• Submit documentation to certification bodies and regulatory authorities as required to obtain product certifications.
• Demonstrated experience working with product standards and their global variants

What you'll bring

• BS or MS in an applicable engineering discipline with 3 or more years of experience in the design and implementation of complex systems.
• Knowledge of EMC regulations and certification procedures applicable to Electromechanical Devices sold worldwide including testing documentation, certification requirements and procedures (i.e. EN14971, EN60601, CISPR 11, FCC, EU etc.).
• Experience in compliance engineering on complex design projects utilizing formal standards testing methodologies.
• Experience in Requirements and Risk Management, Configuration Management, Issue Management and Traceability.
• Experience in resolving complex technical problems in collaboration with design engineers.
• Demonstrated experience interfacing with certification bodies (UL, Intertek, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).
   

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

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 $104,000 - $143,000 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. 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. #LI-ASR2
 

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.