New · posted Nov 10
Baxter · Medical Devices
Sr Engineer, Design Quality
- Batesville, IN
- On-site
- Full-time
- Senior & Principal
The role
This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
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 need
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 IECand 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.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 - $132,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive.
Skills named in this posting
What you'll do
This is where my hands make life-sustaining products
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.
- 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.
Pay and benefits
$96,000 – $132,000 a year
Employer providedWhat we offer from Day One
Shift flexibility to trade shifts and leverage overtime opportunities
Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Where you'll work
Batesville, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Batesville, INEqual opportunity, accessibility and legal noticesBaxter's statements, word for word
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% below the US median for Design Quality & Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $96,000 | — | $132,000 |
| All US (middle half) | $114,500 | $128,000 | $135,000 |
This role: Baxter's own published range. Comparisons: the base pay employers published on open Design Quality & Assurance roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Design Quality & Assurance
The general path across 74 open Design Quality & Assurance roles on Regulatory Jobs, with the titles they carry most. Not Baxter's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership5
- GMP and compliance4
- Lab testing and methods3
- Documentation and SOPs2
- Validation and qualification2
- Quality systems and risk2
- Investigations and CAPA1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Design Quality & Assurance work in medical devices, led by the seven this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devicesNamed in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devicesNamed in the posting
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device softwareNamed in the posting
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipmentNamed in the posting
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA human factors guidance(official source, opens in a new tab)Applying human factors and usability engineering to medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
Company hiring pulse
Baxter on Regulatory Jobs
- 54
- Open roles
- 54
- Distinct roles
- 12
- Locations
By discipline
- Quality49 89%
- Regulatory6 11%
By level
- Associate & Specialist24 44%
- Senior & Principal14 25%
- Manager9 16%
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Sr Engineer, Design Quality at Baxter
Open until filled. $96K–$132K a year, employer provided.