Principal Engineer, Product Design Owner

About the position

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Responsibilities

• Responsible for the management of the design of the Baxter Front Line Care Connected Monitoring products throughout the on-market product lifecycle.
• Provide technical assessment inputs & associated risks in enabling the Business Priority decision for the product and/or design change along with commercial and program inputs.
• Maintain and/or update the product design.
• Ensure compliance, quality and continuity of products in the market.
• Work on technical challenges and risk scenarios and prepare, lead and implement mitigations to ensure optimal results in conjunction with the Sustaining Engineering organization.
• Conduct Design Reviews and technical reviews as required by the quality system.
• Approve, control and own Design History File (DHF) elements, Product and Process Changes, including managing the Risk Management Assessment.
• Drive continuous alignment to FDA, ISO, and IEC design control procedures, regulations and standards ensuring product compliance and regulatory changes/new geographic expansion needs.
• Facilitate change control when required for product support such as SNC, SCAR and complaint investigation.

Requirements

• 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 (sustaining) or other related product development expertise in a regulated industry.
• Knowledgeable in Product Design/Development, Quality System, Lifecycle Management Processes, the intended and actual use of the products, and has technical expertise associated with assigned product and/or domain.
• 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 sufficient to assess changes, incremental risks.
• 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

• Medical and dental coverage that start 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) with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan with options for employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays and 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.