Product Design Owner

Baxter International Inc. • Round Lake, IL

2d • Hybrid

About The Position

The Senior Principal Systems Engineer will serve as a Product Design Owner (PDO), a technical owner for the design and integration of infusion pump systems and/or projects, which combine electro-mechanical hardware, embedded software, and user interface components, as well as the interface with other related EM and/or digital products. The PDO drives operational excellence and predictable, consistent execution in our products, and design integrity. The PDO is accountable for product safety, performance, reliability, usability and regulatory compliance, and is the final decision authority on system architecture, requirements, interfaces and technical risks and trade-offs, and system behavior. The PDO drives design decisions, manages design control activities, and collaborates across engineering disciplines and cross-functions to deliver robust, reliable, safe and innovative infusion therapy solutions.

Requirements

• Has led the transfer of at least one project.
• Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design control
• Bachelor’s degree in engineering (Mechanical, Electrical, Software, or similar) with 8+ years of experience.

Nice To Haves

• Minimum of 5 years of relevant experience in medical device manufacturing industry.

Responsibilities

• Leads interdisciplinary design and development of medical products in compliance with FDA, EU MDR, ISO 13485 and other global regulatory standards to enhance patient outcomes.
• Accountable for end-to-end system traceability completeness
• Has final technical decision authority, leads trade-off analysis and makes critical decisions.
• Ensures technical risks are anticipated and identified, mitigations implemented and aligned with product objectives at all stages of a project.
• Works in close collaboration with Product Risk Owner.
• Accountable for overall product safety, performance, compliance, usability, reliability and quality in the delivered product.
• Accountable for and drives overall product requirements, architecture, interfaces and product design realization, ensuring inclusion of inputs from all stakeholders.
• Understands and resolves competing constraints while driving collaboration of the technical team as well as cross-functionally (engineering, manufacturing, regulatory, clinical, commercial, etc) throughout the product lifecycle.
• Ensures product manufacturability and serviceability.
• Accountable for content and robustness of design reviews and program design changes, and compliance with PDLM processes and procedures, including DHF documentation and audit and regulatory submissions technical preparation.
• Directs and mentors the technical team to complete projects on schedule, ensuring budget goals are met, and all deliverables are of expected quality.
• Accountable for development of technical portion of schedule in conjunction with PMO.
• Fosters a creative, collaborative and innovative environment including focus on innovation and continuous improvement.

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 (RSP), with options for employee contributions and company matching
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior