ShopFloorJobs
Boston Scientific logo

Principal Design Quality Assurance Engineer - Electrophysiology

Boston Scientific · Arden Hills, MN

Apply on Boston Scientific ↗
Level
Senior
Team
Quality
Travel
10%
Degree
Required (or equivalent experience)
Experience asked
10+ years
Industry
Medical devices
Posted
23 days ago

The role in 30 seconds

A senior quality role at Boston Scientific (medical devices) in Arden Hills, MN. Create, maintain and/or support safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, Risk Management Plan, Risk Management Report, and DFMEA.

They ask for
10+ years · degree required (or equivalent experience)
Tools it names
FMEA, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ), MES
Day to day
about 10% travel · relocation help

Read from the posting. The full description is below.

How this role compares

Against 50 other live quality postings in Minnesota.

Base pay
Not listed in this posting

Typical $83k–$131k, from 30 postings that list pay.

Experience asked
More than usual (10+ vs 5+)

Similar roles usually ask 5+ years.

Skills these teams ask for most

  • Root cause 59%
  • Six Sigma 43%
  • ✓ Validation (IQ/OQ/PQ) 43%
  • Lean 39%
  • Supplier quality 39%
  • ✓ FMEA 37%

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

Stands out: this posting asks for MES, which few similar roles mention. If you have it, lead with it.

It asks for 10+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

Relocation help

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. 1

    Pick 2–3 people on the Quality team at Boston Scientific

    We found 10 people at this company and state: 9 on the team, 1 leaders, plus 1 likely hiring manager. Engineers who joined in the last year or two reply the most. See them ↓

  2. 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 Mackenzie → (free)
  3. 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. 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. 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 Arden Hills

12 other open roles at this site · 10 people we found on the quality team.

All 13 roles at Boston Scientific →
Full description from Boston ScientificAs posted on their careers site.Show

About the role

The Principal Design Quality Assurance Engineer will bring their leadership to sustaining projects for our innovative Electrophysiology cardiovascular products portfolio. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

Work Mode

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Arden Hills, MN and requires being on-site at least three days per week.

Relocation assistance

No relocation assistance is available for this position at this time .

Visa sponsorship

Boston Scientific may offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your

Required Qualifications

  • ✓Bachelor’s of Science in Biomedical, Electrical Engineering or equivalent.
  • ✓10 years of medical device engineering experience, with experience in Medical Electrical Equipment/Systems (MEE / MES).
  • ✓Applied knowledge in the design verification and validation of Capital Equipment, including hardware, software, firmware.
  • ✓Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485.
  • ✓Strong leadership, relationship building, and team building skills.
  • ✓Demonstrated ability to mentor and coach others in analysis and risk based decision-making processes to balance business and compliance needs.
  • ✓Strong communication and presentation skills.
  • ✓Strong applied knowledge of statistical concepts, tools, and methodologies.
  • ✓Travel approximately 5-10%.

Minimum Salary: $ 102100

Maximum Salary: $ 194000

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 .

Show full description ↓

Additional Location(s): N/A

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.

include

  • •Lead Quality function for product sustaining teams within the BSC Quality System for Medical Electrical Equipment (MEE) and single use device (SUD) as part of a core group of Design Quality Assurance (DQA) Engineers.
  • •Provide quality and compliance inputs to project teams for project decisions and deliverables (i.e. Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; SW Validation; Process Validation; and Labeling).
  • •Provide quality and compliance inputs for post market product sustaining activities, such as design changes, Non-Conformance Reports (NCEP); Corrective and Preventive Actions (CAPA’s); Product Inquiry Report/Field Action Assessment (PIRs); Field Signals Evaluations and Field Actions.
  • •Create, maintain and/or support safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, Risk Management Plan, Risk Management Report, and DFMEA.
  • •Lead projects as a DQA SME and work with R&D Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
  • •Responsible for collaborating within teams to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
  • •Building quality into all aspects of work by maintaining compliance to all quality requirements.
  • •Support internal and external regulatory audits as required.
  • •Mentor and provide design related technical guidance within the design assurance team.
  • •Other duties as necessary or required by the organization.

More Quality roles nearby