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Johnson & Johnson · 2 months ago

Principal Engineering Project Manager - Console

Danvers, Massachusetts, United States of America

Full-time

Onsite

Senior Level, Lead/Staff

$115K/yr - $198K/yr

7+ years exp

Johnson & Johnson is a leader in healthcare innovation, committed to improving health outcomes. They are seeking a Principal Engineering Project Manager for their Cardiovascular team to lead sustainability efforts for the Impella AIC system, focusing on cybersecurity, compliance, and project management. The role involves cross-functional collaboration to ensure system safety and performance throughout its lifecycle.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Lead cross-functional projects focused on the ongoing support and enhancement, including cybersecurity, obsolescence management, CAPAs, and system upgrades

Collaborate with cybersecurity, IT, and engineering teams to develop and implement security updates, patches, and protocols to protect from emerging threats

Identify components and technologies nearing end-of-life, develop mitigation strategies, and execute replacement or redesign projects to ensure continued compliance and performance

Oversee CAPA processes including root cause analysis, corrective/preventive actions, and verification activities to ensure sustained system integrity

Manage initiatives for component replacements, redesigns, and system upgrades to extend product life and maintain regulatory compliance

Ensure all activities adhere to FDA, ISO, and other relevant standards. Prepare documentation and reports for audits and regulatory submissions

Identify technical and operational risks and develop mitigation plans to minimize impact on product availability and patient safety

Work closely with R&D, Quality, Regulatory, Cybersecurity, Supply Chain, and Manufacturing teams to coordinate activities, share updates, and resolve issues promptly

Develop detailed project plans, milestones, and timelines to ensure timely delivery of sustaining activities, including risk assessments and resource management

Maintain comprehensive records of project activities, progress reports, and regulatory documentation, ensuring transparency and traceability

Qualification

Medical device experienceCybersecurity managementRegulatory complianceProject managementRisk managementCAPA managementObsolescence managementCross-functional collaborationProject planningMS Office SuiteCommunicationLeadership skills

Required

BS in Biomedical, Electrical, Mechanical Engineering, or related scientific discipline

7+ years' experience leading complex sustaining projects in medical device or related industries, with a focus on system support, cybersecurity, and obsolescence management

Proven track record managing CAPAs, lifecycle projects, and regulatory compliance activities

Strong understanding of design controls, risk management, and regulatory requirements (FDA, ISO)

Exceptional project coordination skills, with the ability to multi-task and meet multiple project deadlines

Excellent verbal and written communication, with the ability to present technical information clearly to diverse audiences

Demonstrated leadership in cross-functional teams, motivating team members and managing stakeholder expectations

Experience working with cybersecurity protocols and managing obsolescence projects within regulated environments

Proficiency in project management tools, MS Office Suite, and project budgeting/forecasting

Willingness to travel up to 10% as needed (project-dependent)

Benefits

Medical

Dental

Vision

Life insurance

Short- and long-term disability

Business accident insurance

Group legal insurance

Consolidated retirement plan (pension)

Savings plan (401k)

Long-term incentive program

Vacation – up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

Holiday pay, including Floating Holidays – up to 13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ 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

Represents job field similar to this job

Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)