Product Design Owner

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

The Senior Principal Systems Engineer will serve as a Product Design Owner (PDO) a technical owner for the design and integration of infusion pump systems and/or projects which combine electro-mechanical hardware embedded software and user interface components as well as the interface with other related EM and/or digital products. The PDO drives operational excellence and predictable consistent execution in our products and design integrity. The PDO is accountable for product safety performance reliability usability and regulatory compliance and is the final decision authority on system architecture requirements interfaces and technical risks and trade-offs and system behavior. The PDO drives design decisions manages design control activities and collaborates across engineering disciplines and cross-functions to deliver robust reliable safe and innovative infusion therapy solutions.

What you will be doing:

• Leads interdisciplinary design and development of medical products in compliance with FDA EU MDR ISO 13485 and other global regulatory standards to enhance patient outcomes. Accountable for end-to-end system traceability completeness
• Has final technical decision authority leads trade-off analysis and makes critical decisions. Ensures technical risks are anticipated and identified mitigations implemented and aligned with product objectives at all stages of a project. Works in close collaboration with Product Risk Owner.
• Accountable for overall product safety performance compliance usability reliability and quality in the delivered product.
• Accountable for and drives overall product requirements architecture interfaces and product design realization ensuring inclusion of inputs from all stakeholders.
• Understands and resolves competing constraints while driving collaboration of the technical team as well as cross-functionally (engineering manufacturing regulatory clinical commercial etc) throughout the product lifecycle.
• Ensures product manufacturability and serviceability.
• Accountable for content and robustness of design reviews and program design changes and compliance with PDLM processes and procedures including DHF documentation and audit and regulatory submissions technical preparation.
• Directs and mentors the technical team to complete projects on schedule ensuring budget goals are met and all deliverables are of expected quality.
• Accountable for development of technical portion of schedule in conjunction with PMO.
• Fosters a creative collaborative and innovative environment including focus on innovation and continuous improvement.

What you will bring:

• Has led the transfer of at least one project.

• Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design control

• Bachelors degree in engineering (Mechanical Electrical Software or similar) with 8 years of experience.

• Preferred: Minimum of 5 years of relevant experience in medical device manufacturing industry.

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 $128000 to $176000 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. This position may also be eligible for discretionary bonuses. 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.

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.

#LI-OM1

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.