Principal Design Quality Engineer

Fresenius Medical Care · Lawrence, MA

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Level: Senior
Team: Quality
Base pay: $117k–$196k
Degree: Required
Experience asked: 8+ years
Industry: Medical devices
Posted: 16 days ago

The role in 30 seconds

A senior quality role at Fresenius Medical Care (medical devices) in Lawrence, MA.

They ask for: 8+ years · degree required
Tools it names: Root cause, FMEA, MSA / Gage R&R, CAPA, DOE, Validation (IQ/OQ/PQ)
Base pay: $117k–$196k

Read from the posting. The full description is below.

From the plant jobs report · week of October 19, 2026

Quality Engineer roles in Massachusetts: typical posted base $107k–$149k. This one lists $117k–$196k.

Median of the low and high ends of 50 live postings that list pay, out of 70 quality engineer openings in Massachusetts, read from manufacturers' own careers sites.

Massachusetts plant jobs report →Pay by team and state →What moves pay →

How this role compares

Against 69 other live quality postings in Massachusetts.

Base pay: About 31% above similar roles
Experience asked: More than usual (8+ vs 5+)

Skills these teams ask for most

✓ Root cause 69%
FDA / GMP 60%
✓ Validation (IQ/OQ/PQ) 51%
✓ CAPA 50%
ISO 13485 46%
✓ FMEA 37%

✓ = this posting asks for it too. % = share of similar postings that mention it.

It asks for 8+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone doing this work there first.

At a glance

Lifts up to 50 lbs

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

1
Pick 2–3 people on the Quality team at Fresenius Medical Care
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

Full description from Fresenius Medical CareAs posted on their careers site.Show

Responsibilities

◆Coordinates timely and complete investigations within the assigned manufacturing plant.
◆Ensures compliance to all state and Federal regulations and requirements.
◆Composes and executes design and process verification and validation protocols and reports. Reviews and approves protocols and reports written by other staff as appropriate.
◆Investigates root cause solutions for product release through nonconformance reports (NCR), corrective and preventative actions (CAPA), and material containment and hold forms (MCH) and affected lot hold forms (ALH).
◆Utilizes basic statistical techniques, Experimental Design (DOE), Risk Management, Hazard Analysis and Critical Control Point (HACCP), and Failure Modes and Effects Analysis (FMEA). Conducts and interprets Gage Reproducibility and Repeatability (R&R) studies.
◆Provides support in coordinating plant risk management activities and ensuring risk management techniques are implemented throughout product lifecycle.
◆May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
◆May escalate issues to supervisor/manager for resolution, as deemed necessary.
◆May manage and execute testing and release procedures for finished products.
◆Mentors other staff as applicable.
◆Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
◆Assists with various projects as assigned by a direct supervisor.
◆Other duties as assigned.

Additional

responsibilities

may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

Education

Bachelor’s Degree required; Advanced Degree desirable.

Experience and required skills

✓Minimum 5 – 8 years of related experience; or a Master’s degree with 3 years’ experience.
✓Strong analytical & troubleshooting skills.
✓Ability to understand and employ mathematics at an engineering or scientific level.
✓Strong technical report writing skills.
✓Ability to read, analyze, interpret common scientific and technical reports, technical procedures, governmental regulations.
✓Experience with Correlation and regression Analysis, Experimental Design (DOE), and acceptance sampling; as well as conducting and interpreting gage R&R studies.
✓Strong oral and written communication skills.
✓Strong computer skills, proficient with Microsoft Office.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Show full description ↓

Purpose and scope

Coordinates all efforts for major projects and other significant assignments. Assists in performing disciplined problem solving for supplier, customer, and internal quality defect. Plays an active role in supporting design control activities, concept through release.

Physical demands and working conditions

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to lift up to 50 lbs. as required.

The employee may also be exposed to bovine and human blood products. Hepatitis B Vaccination is recommended.

Engineer/Risk Management focus

•Deep understanding and experience with Risk Management techniques associated with ISO14971-2019. Includes creation of Risk Management Plans, Hazard Analysis/Risk Analysis, Risk Management Reports.
•Understanding Risk linkages to CAPAs, SCARs, NCMRs, complaint handling, and overall quality system.
•Understanding and experience of applying Risk Activities required to support post-market surveillance.
•Understanding and experience applying supportive risk management tools such as dFMEAs, pFMEAs, Use Error Analyses, SW Risk analyses.
•Understanding and applying use of Harms libraries, P1 values, P2 values in premarket and post market settings.
•Ability to review and oversee quality system procedures related to risk management and risk related techniques.

Engineer/Design Assurance Focus

•Deep understanding and experience with Design Control techniques including Design Planning, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, Design Changes, Design Transfer, and Design History Files (Design and Development Files).
•Understanding and experience with applying Design Control linkages to Mfg. Process development and Process Validation.
•Understanding and experience with how Design Controls link into other facts of a quality management system.
•Understanding and experience applying Statistical Techniques in a Design Control context for Design Verification and Validation.
•Understanding of Human Factors/Usability Engineering processes and techniques.

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Annual Rate: $117,000.00 - $196,000.00

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.