Product Design Owner I at Baxter International in Skaneateles, NY

Product Design Owner I Location: Skaneateles, NY This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you will find purpose and pride. Your role at Baxter We’re seeking a strategic and technically skilled Product Design Owner with experience, knowledge and background in Software System and Risk Engineering. This role is central to maintaining advanced connected monitoring devices that integrate real-time patient monitoring, embedded software, and hospital EMR systems, delivering seamless and secure data flow across care settings. As a PDO with software and systems expertise, you’ll bring technical insight into system architecture of hospital integration solutions utilizing your knowledge of connectivity protocols. You will be responsible for ensuring our solutions are robust, scalable, and compliant with healthcare standards. You will be responsible for the management of the design of the Baxter Front Line Care Connected Monitoring products throughout the on-market product lifecycle. The PDO is accountable for the product DHF (Design History File), DMR (Device Master Record)/Master Production and Control Record (MPCR) and Risk Management documentation, or similar product design governance documents for a particular product. As a PDO at Baxter, you will further its mission to empower clinicians and health systems with the tools to make a difference in patients and clinician’s lives. We are looking for someone who is passionate about this work, who empathizes with the functional and psychological needs of the people who experience our products firsthand. What you will be doing Has authority and accountability to maintain and/or update the product design. As key team member of the Connected Monitoring Core Team, responsible for providing technical assessment inputs & associated risks in enabling the Business Priority decision for the product and/or design change along with commercial and program inputs. Ensures compliance, quality, and continuity of products in the market. Ensures consideration of input from external/internal stakeholders (Market, Customer, Regulatory/Compliance, Quality, Service, Manufacturing etc.), drive conflicts to resolution, drive team to agree to a unified decision and drives consideration of these inputs into implementable design solutions. Works on the technical challenges and risk scenarios and prepares, leads & executes mitigations to ensure optimal results in conjunction with the Sustaining Engineering organization. Ensures Design Reviews and technical reviews are conducted as required by the quality system. Approves, controls, and owns Design History File (DHF) elements (may or may not be authoring), Product and Process Changes, including managing the Risk Management Assessment in conjunction with the Product Risk Management Owner. Responsible to drive continuous adherence to FDA, ISO, and IEC design control procedures, regulations and standards ensuring the product compliance and regulatory changes/new geographic expansion needs. Utilizes current product knowledge to facilitate change control when required for product support post-market such as SNCR, SCAR, complaint investigation) or updates to the DHF and technical documentation. Approves the impact assessment of the change and necessary actions. What you will bring Bachelors Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or other relevant subject areas with 5+ years of proven experience. 5+years in product design, systems and risk engineering within the medical device industry. Proven track record in software-enabled product development, especially involving connectivity (Bluetooth, Wi-Fi). Proven application of knowledge in Hardware, Software, and System engineering. Have the knowledge of the regulatory environment for design, development and manufacturing. Knowledge of manufacturing practices and improvements (yield improvements, etc.) sufficient to be able to assess changes, incremental risks. Actively facilitates and negotiates to drive the closure on product/program-related decisions/issues. Ability to work collaboratively as part of a global multi-functional team Familiarity with IEC, ISO, FDA and other regulatory standards and GMP/QSR environment preferred. 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 $112,000 to $154,000 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. 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 employees. For 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.