76 applicants

Company

Original Job Post

Johnson & Johnson · 3 days ago

Design Quality Engineer II

Danvers, MA

Full-time

Onsite

Mid Level

4+ years exp

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Health CareMedical Device

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Support New Product Development Projects Risk Management Deliverables

Use technical expertise to innovate medical devices for chronic heart failure patients

Generate design requirements based on end user needs, standards, and risk evaluations

Develop and review test protocols, reports, and engineering summaries

Perform process development studies and design solutions for manufacturability

Test and analyze engineering prototypes using statistical analysis

Apply problem-solving methodologies to identify and resolve quality issues

Contribute to Quality System performance measures and compliance

Provide support during Corrective and Preventive Action (CAPA) activities

Support 3rd party audits and ensure compliance of QMS through SOPs

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality System RegulationISO 13485MDSAPMDD/MDR21 CFR Part 820ISO 14971CommunicationMedical DevicePharmaceutical IndustryProcess Failure Mode Effects AnalysisDesign ControlNew Product DevelopmentProcess Verification ValidationBlueprint ReadingGD&TInspection Methods

Required

A minimum of a Bachelor's degree in an engineering or scientific discipline is required.

A minimum of 4 years of professional working experience is required.

A minimum of 1+ years of work experience in a highly regulated industry is required or equivalent master’s degree in engineering or scientific discipline.

Must have in-depth knowledge of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP and MDD/MDR.

Working knowledge and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971 is required.

Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.

Preferred

An advanced degree in a related field is an asset.

Medical Device and/or Pharmaceutical industry experience is preferred.

Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.

Design control or new product development is preferred.

Experience supporting or conducting Process Verification / Validation activities is preferred.

Experience with Blueprint reading/literacy including GD&T is preferred.

Familiarity with inspection methods and techniques is an asset.

Company

Johnson & Johnson

Glassdoor

4.2

Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.

Founded in 1886

New Brunswick, New Jersey, USA

10,001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson 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 (43)

2022 (55)

2021 (40)

2020 (30)