Senior Design Quality Engineer - Endoscopy
Boston Scientific · Marlboro, MA
- Level
- Senior
- Team
- Quality
- Travel
- 20%
- Degree
- Required
- Experience asked
- 5+ years
- Industry
- Medical devices
- Posted
- 30+ days ago
The role in 30 seconds
A senior quality role at Boston Scientific (medical devices) in Marlboro, MA. 5 Whys, Is-Is Not, DMAIC and Six Sigma problem solving methodologies) to diagnose root causes, optimize processes, and ensure sustained corrective actions.
- They ask for
- 5+ years · degree required
- Tools it names
- Six Sigma, Root cause, DMAIC, Minitab, ISO 13485, FDA / GMP
- Day to day
- about 20% travel · relocation help
Read from the posting. The full description is below.
How this role compares
Against 56 other live quality postings in Massachusetts.
- Base pay
- Not listed in this posting
- Experience asked
- Typical (5+ years)
Typical $97k–$130k, from 35 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 72%
- ✓ FDA / GMP 53%
- ✓ Validation (IQ/OQ/PQ) 53%
- ✓ ISO 13485 47%
- FMEA 44%
- CAPA 44%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for DMAIC, 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 Boston Scientific
We found 3 people at this company and state: 3 on the team. 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 Saurabh → (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 20% 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: Boston Scientific in Marlboro
4 other open roles at this site · 3 people we found on the quality team.
- Design Assurance Quality Engineer III · Quality · Senior
- Quality Systems Engineer III · Quality · Senior
- Supplier Quality Engineer II - Endoscopy SFMD · Quality
- Design Quality Assurance Engineer III - Endoscopy · Quality · Senior
Full description from Boston ScientificAs posted on their careers site.ShowHide
requirements
and best practices.
- ✓Lead the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change Analysis, and Design & Usability Validation Plans.
- ✓Leads the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety.
- ✓Establishes strong relationships across departments, effectively communicating quality priorities, presenting findings, and driving consensus among stakeholders. Uses influence and negotiation skills to integrate quality perspectives into business decisions.
- ✓Identifies and implements best-in-class practices for the department. Proactively assesses opportunities for improvements or enhancement to quality systems and processes in the company.
Required Qualifications
- ✓BS in Biomedical Engineering, Mechanical Engineering or related degree.
- ✓5+ years of medical device engineering experience.
- ✓Firm understanding of DMAIC system and proven history of problem solving
- ✓Detailed understanding and working knowledge of US and International medical device
requirements
including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
- ✓Travel approximately 10-20%.
Preferred Qualifications
- ✓8+ years of medical device engineering experience.
- ✓Proficiency in Minitab Statistical Analysis software or equivalent.
- ✓Six Sigma Certification.
- ✓Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies.
- ✓Excellent communication, presentation, and interpersonal skills, with the ability to influence teams and leadership.
- ✓Proven ability to lead and coach others, driving a high-performance quality culture.
- ✓Strategic mindset with hands-on execution, balancing long-term objectives with immediate project needs.
Minimum Salary: $ 89200
Maximum Salary: $ 169500
For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .
Boston Scientific Corporation has been and will continue to be an e
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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About this role
The Senior Design Quality Assurance Engineer will provide direct DQA support to a team focused on solving complex technical challenges across the Endoscopy portfolio and transforming technical insights into meaningful product improvements, design enhancements, and portfolio value creation.
The position is part team that will engage in the most critical and complex issues impacting performance across the portfolio. Through that work, they will enable the longer-term objective of building a robust pipeline of iterative innovations, design improvements, and market-facing product enhancements.
Work mode
At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA and requires being on-site at least three (3) days per week.
Relocation assistance
Relocation assistance may be available for this position at this time.
Visa sponsorship
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your
include
- •Leverages deep technical knowledge to lead teams through complex problem-solving initiatives. Applies systematic approaches (e.g. 5 Whys, Is-Is Not, DMAIC and Six Sigma problem solving methodologies) to diagnose root causes, optimize processes, and ensure sustained corrective actions.
- •Create and interpret data needed to make the best data driven decisions possible.
- •Acts as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory