103 applicants

Company

Original Job Post

Boston Scientific · 5 days ago

Design Quality Engineer II

Marlborough, MA

Full-time

Hybrid

Mid Level

2+ years exp

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Responsibilities

Act as an effective leader or cross-functional team member in supporting quality disciplines, decisions, and practices.

Effectively work with and influence cross-functional teams during the Design Change process to ensure proposed changes to products are analyzed, assessed, controlled, and implemented appropriately.

Support planning, updating, and maintenance of product Risk Management documentation in compliance with Boston Scientific procedures and external standards.

Support Usability Engineering and planning documentation.

Interface with the core team and support manufacturing operation efforts/changes to ensure they meet or exceed internal and external requirements.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Support post-market activities ensuring products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals.

Support internal and external regulatory audits as required.

Qualification

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2 years related experienceMedical Device IndustryISO 13485ISO 14971Quality System RegulationsMedical Electrical SystemsProblem SolvingCommunicationTeamwork

Required

Minimum of a Bachelor’s Degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)

Minimum of 2 years of related experience

Travel approximately <10%

Preferred

Experience in the Medical Device industry (quality and risk management) and medical electrical systems

Detailed understanding of ISO 13485, ISO 14971, and Quality System Regulations

Skillful problem solver, capable of facilitating the problem-solving process and driving to solutions in a timely manner

Ability to work in a fast-paced, dynamic environment while promoting / fostering cross-functional teamwork

Strong communication skills (verbal & written)

Company

Boston Scientific

Glassdoor

4.2

Boston Scientific is an innovator of medical solutions that improve patient health.

Founded in 1979

Marlborough, Massachusetts, USA

10,001+ employees

http://www.bostonscientific.com

H1B Sponsorship

Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2020 (98)