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Company

Original Job Post

Boston Scientific · 4 days ago

Design Quality Engineer II

Marlborough, MA

Full-time

Onsite

Entry, Mid Level

2+ years exp

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Responsibilities

Execute Quality Deliverables: Drive the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, and Design Change Assessment. Lead product usability and design validation efforts.

Design Controls: Provide quality and compliance input for project decisions and deliverables. Ensure country-specific compliance to laws and regulations. Measure and oversee the quality of internal and external suppliers.

Manufacturing Engineering: Provide product-specific manufacturing quality assurance expertise. Approve manufacturing PDP and Design Controls deliverables.

Audit Support: Support internal and external regulatory audits.

Product Support: Provide key quality trending information and data. Support CAPA efforts and apply problem-solving methodologies for quality issues.

Qualification

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Medical Device EngineeringFDA RegulationsISO StandardsQuality RequirementsProduct DevelopmentDesign ControlsProduct Risk ManagementUS RegulationsInternational RegulationsMicrosoft OfficeMinitab Statistical AnalysisCommunicationPresentation

Required

BS in Mechanical, Electrical, or Biomedical Engineering

Minimum of 2 years of medical device engineering experience

Travel approximately 10-15% of the time

In depth familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product development, design controls, and product risk management

Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, and EN 62366

Strong communication and presentation skills

Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)

Preferred

3+ years of medical device engineering experience preferred

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)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (68)

2022 (128)

2021 (130)

2020 (98)