Sr. Quality Engineer - Post-Market Vigilance - Onsite
Medtronic · Irvine, CA
- Level
- Senior
- Team
- Quality
- Base pay
- $98k–$148k
- Degree
- Required
- Experience asked
- 4+ years
- Industry
- Medical devices
- Posted
- 2 days ago
The role in 30 seconds
A senior quality role at Medtronic (medical devices) in Irvine, CA. In this role, the Senior Quality Engineer will provide engineering leadership for the evaluation and resolution of post-market product quality and safety issues across the Neurovascular portfolio.
- They ask for
- 4+ years · degree required
- Tools it names
- Root cause, FDA / GMP, Supplier quality
- Base pay
- $98k–$148k
Read from the posting. The full description is below.
From the plant jobs report · week of October 26, 2026
Quality Engineer roles in California: typical posted base $100k–$148k. This one lists $98k–$148k.
Median of the low and high ends of 93 live postings that list pay, out of 190 quality engineer openings in California, read from manufacturers' own careers sites.
California plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 189 other live quality postings in California.
- Base pay
- In line with similar roles
- Experience asked
- Less than usual (4+ vs 5+)
Typical $100k–$148k, from 90 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 78%
- FMEA 55%
- ✓ Supplier quality 48%
- Validation (IQ/OQ/PQ) 45%
- AS9100 43%
- ISO 9001 39%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for FDA / GMP, which few similar roles mention. If you have it, lead with 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 Medtronic
We found 4 people at this company and state: 3 in this kind of role, 1 leaders, plus 1 likely hiring manager. 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 Glenn → (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?
- 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: Medtronic in Irvine
1 other open role at this site · 4 people we found in quality roles at Medtronic.
- Senior Value Stream Manager - PVH · Lean / CI · Manager
Full description from MedtronicAs posted on their careers site.ShowHide
requirements
and standards.
Required Qualifications
- ✓4+ years of experience required with a Bachelor's Degree OR 2+ years of experience required with a Masters Degree OR 0+ years of experience required with a Ph.D.
- ✓Strong statistical data analysis skills with ability to analyze complex data sets
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the
requirements
of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Physical Job
Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required
responsibilities
and skills of this position.
The physical demands described within the
Responsibilities
section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical
requirements
that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where emplo
Show full description ↓Show less ↑
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
At Medtronic Neuroscience, we bring innovation, expertise, and purpose together to improve outcomes and transform lives for people living with neurological, spine, and chronic pain conditions.
Our Neurovascular Operating Unit advances stroke and cerebrovascular care through innovative, minimally invasive technologies that enable rapid, life-saving intervention. From restoring blood flow to securing complex vascular conditions, our solutions help clinicians achieve better outcomes when every second counts.
Check us out on LinkedIn: Medtronic Neurovascular
In this role, the Senior Quality Engineer will provide engineering leadership for the evaluation and resolution of post-market product quality and safety issues across the Neurovascular portfolio. The engineer will apply product design knowledge, engineering analysis, risk management, statistics, and data analytics to characterize device performance, investigate field-reported failure modes, determine root cause, and assess potential patient and product impact. This role partners closely with R&D, Manufacturing Engineering, Supplier Quality, Regulatory, Clinical, and Operations to translate post-market signals into technically sound risk controls, product improvements, and sustained product reliability while ensuring compliance with applicable regulatory requirements.
Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
This position is on-site in Irvine, CA 4 days/week, with the option to work 1 day/week of your choosing remote.
Engineering Investigation and Issue Resolution
- •Lead engineering evaluations of post-market complaints and product performance signals, including assessment of device failure modes, use conditions, patient impact, and potential product risk.
- •Plan and lead complex technical investigations using engineering problem-solving methods, product and process knowledge, returned-device analysis, test data, manufacturing records, and supplier information.
- •Develop and document technically supported root cause and failure-mechanism conclusions, including clear evaluation of evidence, limitations, and residual uncertainty.
- •Partner with R&D, Manufacturing Engineering, Supplier Quality, Regulatory, Clinical, Marketing, and Operations to define containment, product controls, corrective actions, and design or process improvements based on investigation findings.
Product Risk and Post-Market Engineering
- •Apply design control and risk management principles throughout the product lifecycle to evaluate whether post-market information changes known hazards, failure modes, risk estimates, or the adequacy of existing controls.
- •Review and develop engineering test strategies, protocols, methods, and reports to ensure evaluations are technically appropriate, statistically sound, and sufficient to support quality and regulatory decisions.
- •Perform complaint trending, signal detection, and data analysis to identify emerging product performance issues and distinguish meaningful signals from expected variation.
- •Translate engineering evidence into clear technical recommendations for Product Evaluation Boards, health hazard analyses, product hold decisions, field corrective actions, and other escalation pathways.
- •Use large and complex data sets to characterize failure patterns by product, lot, component, manufacturing process, clinical use, and other relevant engineering variables.
- •Maintain strong working knowledge of Neurovascular device design, materials, manufacturing processes, clinical use, and applicable FDA and international medical device