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Senior Design Quality Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)

Boston Scientific · Arden Hills, MN

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Level
Senior
Team
Quality
Degree
Required
Experience asked
5+ years
Industry
Medical devices
Posted
9 days ago

The role in 30 seconds

A senior quality role at Boston Scientific (medical devices) in Arden Hills, MN. Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

They ask for
5+ years · degree required
Tools it names
FMEA, ISO 13485, Validation (IQ/OQ/PQ)
Day to day
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
Typical (5+ years)

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.

It asks for 5+ 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.

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  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?
    • 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

This Senior Design Quality Engineer position will support active implantable medical devices. This position will serve as a quality representative on product development projects and will collaborate with cross functional teams including R&D, process development, manufacturing, and regulatory affairs to help ensure that the product and processes remain safe, of high quality, and compliant with BSC and regulatory

requirements

throughout the product lifecycle process.

requirements

and internal standards.

  • ✓Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
  • ✓Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • ✓Partner cross-functionally to identify and support value improvement efforts to support business goals.
  • ✓Directly interfaces with internal and external audit activities.

Required qualifications

  • ✓Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
  • ✓5+ years of experience in design assurance, new product development or related medical device / regulated industry experience.
  • ✓Self-motivated with a passion for solving problems and a bias for action.
  • ✓Strong communication skills (verbal & written). Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise.
  • ✓Demonstrated use of Quality tools/methodologies.
  • ✓Ability to effectively work and collaborate in a mixed onsite + remote environment.
  • ✓Experience writing specifications, test protocols, and technical reports.

Preferred qualifications

  • ✓Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).
  • ✓ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
  • ✓Experienced problem solver, capable of facilitating the problem-solving process.
  • ✓Adaptable and effective collaborator in a team environment or in self-directed work.
  • ✓Experience with design changes, complaint reduction, and corrective action.

Minimum Salary: $ 85000

Maximum Salary: $ 161500

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

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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.

Work Mode

Boston Scientific values collaboration, and this hybrid role requires employees to work from the Arden Hills, MN office at least three days per week.

Relocation Assistance

Relocation assistance is not available for this position.

Visa Sponsorship

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

Your

will include

  • •Owns and drives deliverables related to Risk Management, Design Controls, Product Performance, Quality, and Compliance.
  • •Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
  • •Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).
  • •Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • •Acts as an effective team member in supporting quality disciplines, decisions, and practices.
  • •Work within a cross-functional team to identify and implement effective controls for new technology in complex medical devices.
  • •Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
  • •Develops and implements quality strategies; seeks innovative approaches to attain quality goals.
  • •Support Post Market activities, as necessary, of risk based on post-market signals.
  • •Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
  • •Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory

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