Product Owner I

Baxter International Inc.

Product Design Owner managing advanced connected monitoring devices integrating real-time patient monitoring. Ensuring compliance, quality and continuity within medical device regulations at Baxter.

Posted 5/20/2026full-timeSkaneateles • New York, Wisconsin • 🇺🇸 United StatesMid-LevelSenior💰 $112,000 - $154,000 per yearWebsite

About the role

Key responsibilities & impact

Maintain and/or update the product design
Responsible for providing technical assessment inputs & associated risks
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.)
Works on the technical challenges and risk scenarios and prepares, leads & executes mitigations
Ensures Design Reviews and technical reviews are conducted as required by the quality system
Approves, controls, and owns Design History File (DHF) elements
Responsible to drive continuous adherence to FDA, ISO, and IEC design control procedures, regulations and standards

Requirements

What you’ll need

Bachelor's Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or other relevant subject areas
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
Knowledge of the regulatory environment for design, development and manufacturing
Knowledge of manufacturing practices and improvements (yield improvements, etc.)
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

Benefits

Comp & perks

Medical and dental coverage starting on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

product designrisk engineeringsoftware-enabled product developmentconnectivityBluetoothWi-Fihardware engineeringsoftware engineeringsystem engineeringmanufacturing practices

Soft Skills

collaborationstakeholder engagementtechnical assessmentrisk managementquality assurancecontinuous improvementleadershipcommunication