Sr Compliance Engineer

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

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 Youll 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 youll 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 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 $88000 - $121000 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.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident short-term and long-term disability and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount and the 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching. We also offer Flexible Spending Accounts educational assistance programs and time-off benefits such as paid holidays paid time off ranging from 20 to 35 days based on length of service family and medical leaves of absence and paid parental leave. Additional benefits include commuting benefits the Employee Discount Program the Employee Assistance Program (EAP) and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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 link 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 Recruitment Fraud Notice.