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Design Quality Engineer III - Interventional Cardiology

Boston Scientific · Maple Grove, MN

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

The role in 30 seconds

A senior quality role at Boston Scientific (medical devices) in Maple Grove, MN. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

They ask for
3+ years · degree required
Tools it names
FMEA, Validation (IQ/OQ/PQ)
Day to day
relocation help

Read from the posting. The full description is below.

It asks for 3+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

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  2. 2

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  5. 5

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About the role

About the role

Boston Scientific is currently recruiting for a Sustaining Design Quality Engineer III in our Arbor Lakes, MN location. This is an exciting opportunity to participate in the quality assurance of our medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC.

The Design Quality Engineer III will support application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products.

Required qualifications

  • ✓Bachelor’s degree in an engineering discipline
  • ✓Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience
  • ✓Knowledge of basic Quality System

Requirements

and Good Documentation Practices

Preferred qualifications

  • ✓Bachelor’s degree in mechanical, electrical, or biomedical engineering
  • ✓Experience with design control, risk management, and medical device standards compliance
  • ✓Experience with corrective and preventive action
  • ✓Adaptable and effective collaborator in a team environment and in self-directed work
  • ✓Strong communication skills (verbal & written)

Minimum Salary: $ 78300

Maximum Salary: $ 148800

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 .

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and se

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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

At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Arbor Lakes Campus in Maple Grove, MN 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

will include

  • •Ownership of design change projects including scoping, assessment, and implementation.
  • •Develop, update, and maintain Design History File and Design Input / Output documentation
  • •Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
  • •Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
  • •Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
  • •Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • •Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

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