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Company

Original Job Post

Johnson & Johnson · 4 days ago

Principal Software Design Quality Engineer

Danvers, MA

Full-time

Onsite

Senior Level

8+ years exp

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Health CareMedical Device

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Lead Design Quality Engineering activities for Software Product Development and Software Life Cycle processes

Ensure compliance with design controls, quality planning, risk assessments, and regulatory requirements

Participate in design reviews, approve design input/output artifacts, and review Engineering Change Orders

Contribute to product assurance plans and provide feedback for corrective and preventative actions

Collaborate with cross-functional teams to ensure compliance with quality systems and regulations

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 EngineeringFDA RegulationsISO StandardsMedical Device Industry KnowledgeClass III Medical DevicesMedical Device SoftwareCardiovascular DevicesProblem-SolvingAttention to Detail CommunicationTIR45Agile MethodologiesInitiativeLeadershipTeamwork

Required

Bachelor degree in Engineering or Sciences is required, Masters preferred

8+ years of quality experience required

Minimum of 5 years experience in the medical device industry as well as Medical Device Software systems and cardiovascular devices highly preferred (Class III medical device experience strongly preferred)

Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements

Preferred

Familiarity with TIR45 and Agile methodologies preferred

Takes initiative and demonstrates leadership and teamwork

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)