Principal Engineer, PDO
Job Description
Baxter Healthcare is seeking a Principal Engineer, PDO (Product Design Owner) to join their R&D organization in Skaneateles, NY. This role represents a unique opportunity to directly impact patient care through medical device development and lifecycle management.
The position sits at the intersection of engineering and healthcare, requiring a blend of technical expertise and regulatory knowledge. As a PDO, you'll be responsible for managing the design of Baxter Front Line Care Legacy products throughout their market lifecycle, ensuring both innovation and compliance with strict medical device regulations.
The role offers an attractive compensation package ranging from $104,000 to $143,000 annually, complemented by comprehensive benefits including medical coverage, 401(k) matching, and stock purchase options. Baxter's commitment to healthcare innovation is backed by 87 years of industry experience and a global presence.
Key responsibilities include providing technical assessments, maintaining product design integrity, ensuring regulatory compliance, and leading technical reviews. You'll work within a collaborative R&D environment where your decisions directly influence product quality and patient outcomes.
The ideal candidate brings 5+ years of experience in product lifecycle management, with a strong foundation in hardware, software, and systems engineering. Knowledge of FDA, ISO, and IEC standards is essential, as is the ability to work effectively in a regulated industry environment.
This role offers the opportunity to:
- Lead critical product design initiatives in medical technology
- Work with cutting-edge healthcare innovations
- Join a company with a strong mission of saving and sustaining lives
- Develop expertise in both technical and regulatory aspects of medical devices
- Collaborate with global cross-functional teams
Baxter offers a supportive work environment with emphasis on professional development, work-life balance, and meaningful impact. The position requires on-site presence in Skaneateles, NY, allowing for direct collaboration with R&D teams and hands-on product development work.
Responsibilities For Principal Engineer, PDO
- Manage design of Baxter Front Line Care Legacy products throughout product lifecycle
- Provide technical assessment inputs & associated risks for product and design changes
- Maintain and update product design
- Ensure compliance, quality and continuity of products in the market
- Lead technical challenges and risk scenarios implementation
- Conduct Design Reviews and technical reviews
- Manage Design History File (DHF) elements and Product/Process Changes
- Drive alignment to FDA, ISO, and IEC design control procedures
- Facilitate change control for product support
Requirements For Principal Engineer, PDO
- Bachelors Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or other relevant subject areas with 5+ years of proven experience
- 5+ years of validated experience in product lifecycle management or product development in a regulated industry
- Knowledge in Product Design/Development, Quality System, Lifecycle Management Processes
- Proven application of knowledge in Hardware, Software, and System engineering
- Knowledge of manufacturing practices and improvements
- 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
Benefits For Principal Engineer, PDO
- Medical and dental coverage from day one
- Life insurance
- Short-term and long-term disability insurance
- Employee Stock Purchase Plan (ESPP)
- 401(k) Retirement Savings Plan with company matching
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays
- 20-35 days paid time off based on service length
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- Childcare benefits
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