Principal Engineer, PDO
Job Description
Baxter, a leading global healthcare company with over 85 years of history, is seeking a Principal Engineer, PDO (Product Design Owner) to join their R&D organization. This role represents a unique opportunity to directly impact patient care through product design and development.
The position involves managing the design of Baxter Front Line Care Legacy products throughout their lifecycle, working at the intersection of hardware, software, and systems engineering. As a key member of the Legacy Core Team, you'll be responsible for technical assessments, risk management, and ensuring product compliance with FDA, ISO, and IEC standards.
The role offers a comprehensive benefits package including medical coverage, 401(k) with company matching, stock purchase options, and flexible work arrangements. Based in Skaneateles, NY, you'll be part of a collaborative, mission-driven team focused on saving and sustaining lives through healthcare innovation.
This is an ideal opportunity for an experienced engineer with a background in regulated industries who wants to make a meaningful impact in healthcare. You'll work with cross-functional teams, lead technical reviews, and drive continuous improvement in product design and development. The position offers competitive compensation ranging from $104,000 to $143,000 annually, plus additional benefits and bonus potential.
The role requires strong technical expertise combined with leadership skills, as you'll be responsible for maintaining design history files, managing risk assessments, and ensuring product quality and compliance. You'll be joining a company known for its commitment to innovation and improving patient outcomes worldwide.
Responsibilities For Principal Engineer, PDO
- Manage design of Baxter Front Line Care Legacy products throughout product lifecycle
- Provide technical assessment inputs & associated risks for Business Priority decisions
- Maintain and update product design
- Ensure compliance, quality and continuity of products in the market
- Work on technical challenges and risk scenarios
- Conduct Design Reviews and technical reviews
- Approve, control and own Design History File (DHF) elements
- Drive alignment to FDA, ISO, and IEC design control procedures
- Facilitate change control for product support
- Manage Risk Management Assessment
Requirements For Principal Engineer, PDO
- Bachelors Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or other relevant subject areas
- 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 regulatory environment for design, development and manufacturing
- 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 preferred
Benefits For Principal Engineer, PDO
- Comprehensive medical and dental coverage from day one
- Life insurance coverage
- Short-term and long-term disability insurance
- 401(k) Retirement Savings Plan with company matching
- Employee Stock Purchase Plan (ESPP)
- Flexible Spending Accounts
- Educational assistance programs
- 20-35 days paid time off based on length of service
- Paid holidays
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- Childcare benefits
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