Principal Quality Engineer - Johnson & Johnson MedTech, Circulatory Restoration (Shockwave Reducer)
Johnson & Johnson MedTech · New Brighton, MN
- Level
- Senior
- Team
- Quality
- Base pay
- $102k–$177k
- Travel
- 10%
- Degree
- Required
- Experience asked
- 10+ years
- Industry
- Medical devices
- Posted
- Yesterday
The role in 30 seconds
A senior quality role at Johnson & Johnson MedTech (medical devices) in New Brighton, MN. Johnson & Johnson is hiring for a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business located in New Brighton, MN.
- They ask for
- 10+ years · degree required
- Tools it names
- FMEA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ), Supplier quality
- Base pay
- $102k–$177k
- Day to day
- about 10% travel
Read from the posting. The full description is below.
From the plant jobs report · week of October 26, 2026
Quality Engineer roles in Minnesota: typical posted base $85k–$141k. This one lists $102k–$177k.
Median of the low and high ends of 34 live postings that list pay, out of 57 quality engineer openings in Minnesota, read from manufacturers' own careers sites.
Minnesota plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 56 other live quality postings in Minnesota.
- Base pay
- About 28% above similar roles
- Experience asked
- More than usual (10+ vs 5+)
Typical $83k–$135k, from 31 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Root cause 56%
- ✓ Validation (IQ/OQ/PQ) 42%
- Lean 40%
- Six Sigma 40%
- ✓ Supplier quality 40%
- ✓ FMEA 37%
✓ = this posting asks for it too. % = share of similar postings that mention it.
At a glance
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 Johnson & Johnson MedTech
We found 3 people at this company and state: 3 in this kind of role. Engineers who joined in the last year or two reply the most. See 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.
Write to Joanna → (free) - 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?
- The posting says about 10% travel. Between which sites?
- 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.
This plant: Johnson & Johnson MedTech in New Brighton
No other open roles at this site right now · 3 people we found in quality roles at Johnson & Johnson MedTech.
Full description from Johnson & Johnson MedTechAs posted on their careers site.ShowHide
requirements
- ✓Serve as technical subject matter expert on regulatory standards, statistical methods, test design, and acceptance criteria
- ✓Participate in design reviews to provide an independent perspective on compliance and risk
- ✓Ensure Design History Files (DHFs) are complete, accurate, and inspection-ready throughout the development lifecycle
- ✓Develop and maintain Risk Management Files including plans/reports, hazard analyses, FMEAs, risk control strategies, and risk assessments
- ✓Support development and execution of incoming inspection plans, first article inspections (FAI), and related documentation to ensure alignment with design intent
- ✓Advise design teams on quality system and regulatory implications of design decisions and changes
- ✓Provide Design Assurance oversight for Verification and Validation (V&V) activities
- ✓Review and approve protocols, test methods, and reports
- ✓Provide quality oversight to ensure test strategies, acceptance criteria, and sample sizes are appropriate and compliant with applicable standards
- ✓Serve as a quality advisor for V&V activities including biocompatibility, sterilization validation, packaging validation, and shelf‑life studies
- ✓Lead or support test method validation (TMV) activities to ensure methods are suitable for their intended use and comply with internal and regulatory expectations
- ✓Perform or witness hands-on Design V&V testing when needed to support design assurance assessments
- ✓Partner with to Manufacturing and Operations on design transfer and validation
- ✓Support equipment and process validation activities (IQ/OQ/PQ) associated with new product introduction
- ✓Ensure manufacturing processes, controls, and validations support design intent and regulatory
requirements
- ✓Support Contract Manufacturing and Supplier Quality in identifying, qualifying, and managing suppliers to support new product development and design transfer
- ✓Participate in FDA, Notified Body, and ISO 13485 audits/inspections
- ✓Contribute to regulatory submissions (510(k), CE Technical Files, PMA modules)
- ✓Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interaction
Show full description ↓Show less ↑
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function
Supply Chain Engineering
Job Sub Function
Quality Engineering
Job Category
Scientific/Technology
All Job Posting Locations
New Brighton, Minnesota, United States of America
Job Description
Johnson & Johnson is hiring for a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business located in New Brighton, MN.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Cardiovascular Solutions from Johnson & Johnson
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary and peripheral artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more information on circulatory restoration, visit our website.
Position Overview
The Principal Quality Engineer (Design Assurance) is responsible for ensuring medical devices are designed, developed, and transferred to manufacturing in compliance with applicable quality system and regulatory requirements. This role partners closely with R&D, Manufacturing, Regulatory Affairs, Clinical Affairs, and Marketing to provide hands-on Design Assurance support throughout new product development. This role applies and interprets relevant medical device standards and regulations as they relate to design and development activities, advising design teams on the quality and compliance impacts of design decisions. Operating with a high degree of autonomy, the Principal Quality Engineer is expected to influence design assurance strategy across programs, provide mentoring and technical guidance to senior engineers, and serve as a subject matter expert during regulatory interactions. This role provides practical, execution‑focused quality engineering support with an emphasis on risk management, verification and validation oversight, and design transfer, enabling timely and compliant product launches.
Essential Job Functions
Lead quality assurance for new product development
- •Partner with design teams to ensure compliance with ISO 13485 and applicable regulatory
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