Sr Engineer, Design Quality
Baxter International Inc.
Summary
As a Senior Engineer, Design Quality, you will serve as the quality partner for New Product Development and Sustaining Engineering projects. You will provide quality oversight throughout the product lifecycle, ensuring design controls, regulatory requirements, and quality standards are met. Working closely with cross-functional teams, you will identify and mitigate quality risks while helping deliver safe, effective, and compliant medical devices.
Job description
Your Role at Baxter
As a Senior Engineer, Design Quality, you will serve as the quality partner for New Product Development and Sustaining Engineering projects. You will provide quality oversight throughout the product lifecycle, ensuring design controls, regulatory requirements, and quality standards are met. Working closely with cross-functional teams, you will identify and mitigate quality risks while helping deliver safe, effective, and compliant medical devices.
Your Team
You will join a collaborative Quality team that partners with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality to bring innovative healthcare products to market. Together, you will drive quality excellence, support compliance, manage risk, and help improve outcomes for patients around the world.
What you'll be doing
- Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities.
- Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.
- Provide quality assurance support and oversight for product design activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.
- Ensure compilation and maintenance of product Design History Files in collaboration with R&D.
- Partner with Sustaining Engineering and Research & Development to ensure design reviews are thorough and robust.
What you'll bring
- Bachelor's degree in engineering
- 3-5 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.
- Strong problem-solving and root cause analysis skills.
- Experience with structured methods such as 5 Why, fault tree analysis, design or process Failure Modes and Effects Analysis, DMAIC, or equivalent approaches is preferred.
- Demonstrated working knowledge of medical device design controls and product lifecycle management for New Product Development and sustaining activities.
- Working knowledge of applicable quality system and risk management requirements, including ISO 13485, ISO 14971, Regulation (EU) 2017/745, and U.S. FDA Quality System requirements.
- Knowledge of applicable IEC and ISO product standards (ex: IEC 62304, IEC 60601-1, ISO 62366-1, etc…) is expected for the assigned product scope
- Ability to review technical documentation and determine whether requirements, methods, results, conclusions, and traceability are scientifically and objectively supported
- Ability to apply or critically review statistical methods used for verification, validation, reliability, sampling, and process or product data analysis.
- Strong written and verbal communication skills. Able to explain complex quality or technical topics clearly to technical teams and management.
- Self-motivated, organized, detail oriented, and able to manage multiple priorities while maintaining accurate and complete records.
- Ability to challenge constructively, make decisions, and escalate concerns when evidence is insufficient or patient safety, product quality, or compliance may be affected.
- Experience supporting audits or regulatory inspections is preferred.
- Professional certification in quality engineering, reliability, software quality, Lean, or Six Sigma is preferred.
- Experience with working in an environment subject to compliance with 21 CFR Parts 820, and FDA Inspection experience preferred.
Requirements
- Bachelor's degree in engineering
- 3-5 years experience in Quality with a medical device / Pharma company or other similarly regulated industry
- Strong problem-solving and root cause analysis skills
- Demonstrated working knowledge of medical device design controls and product lifecycle management
- Working knowledge of ISO 13485, ISO 14971, Regulation (EU) 2017/745, and U.S. FDA Quality System requirements
- Knowledge of applicable IEC and ISO product standards (e.g., IEC 62304, IEC 60601-1, ISO 62366-1)
- Ability to review technical documentation for scientific and objective support
- Ability to apply or critically review statistical methods for verification, validation, reliability, sampling, and data analysis
- Strong written and verbal communication skills
- Self-motivated, organized, detail oriented, able to manage multiple priorities
- Ability to challenge constructively, make decisions, and escalate concerns
- Experience with structured methods such as 5 Why, fault tree analysis, FMEA, DMAIC (preferred)
- Experience supporting audits or regulatory inspections (preferred)
- Professional certification in quality engineering, reliability, software quality, Lean, or Six Sigma (preferred)
- Experience with 21 CFR Part 820 compliance and FDA inspections (preferred)
- Must be authorized to work for an employer in the U.S.
Benefits
- Shift flexibility
- Medical, Dental & Vision
- 160 hours PTO
- Paid Holidays
- 401(k) Matching
- Employee Stock Purchase Program
- Paid Parental Leave
- Tuition Reimbursement
- Life Insurance
- Accident Insurance
- Short-term Disability
- Long-term Disability
- Business Travel Accident Insurance
- Flexible Spending Accounts
- Childcare Benefits
- Employee Assistance Program
- Commuting Benefits
- Employee Discount Program
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.