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Engineering Project Manager - Console, Innovation Excellence

Engineering Project Manager - Console, Innovation Excellence

J&J Family of CompaniesDanvers, MA, US
5 days ago
Job type
  • Full-time
Job description

Engineering Project Manager - Console, Innovation Excellence

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

ABIOMED is redefining team-driven success while reshaping heart recovery. Here, innovation is driven by continuous improvement and a passion for saving lives. We are seeking a highly motivated and experienced Project Manager to lead the ongoing sustainability of the Impella AIC system. This critical role involves managing cybersecurity initiatives, obsolescence mitigation projects, CAPAs, and other sustaining activities to ensure the system's safety, compliance, and performance over its lifecycle.

The successful candidate will have a strong background in medical devices, with demonstrated leadership in managing complex projects that span technical, regulatory, and operational domains. This role requires an inspirational and collaborative leader capable of working across functions, including engineering, quality, regulatory, supply chain, and cybersecurity, to ensure the Impella AIC continues to meet the highest standards of safety and efficacy.

Principal Duties and 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.

Job Qualifications :

  • 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).
  • Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

    Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https : / / www.jnj.com / contact-us / careers or contact AskGS to be directed to your accommodation resource.

    The anticipated base pay range for this position is 115,000.00 to 197,800.00.

    The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar / performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and / or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401k). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits : 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.

    This job posting is anticipated to close on November 30, 2025. The Company may however extend this time-period, in which case the posting will remain available on https : / / www.careers.jnj.com to accept additional applications.

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