Johnson & Johnson MedTech · 3 days ago
Principal Engineering Project Manager - Console
Danvers, MA
Full-time
Onsite
Senior Level, Lead/Staff
$115K/yr - $198K/yr
7+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focusing on developing smarter and less invasive treatments. The Engineering Project Manager - Console will lead initiatives to ensure the safety, compliance, and performance of the Impella AIC system through project leadership, cybersecurity oversight, and cross-functional collaboration.
Hospital & Health Care
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
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 MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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