Project Manager, Medical Devices & Service

6942-ABIOMED Inc. Legal Entity; Danvers (MA); On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

Paid time off

Job summary

Johnson & Johnson in Danvers, MA is seeking a Project Manager, Service & Repair to lead cross-functional initiatives in cardiovascular care. You will ensure projects are delivered safely, on time, and in line with quality, regulatory, and operational standards.

The role requires a bachelor’s degree (Business/Engineering/Construction/Operations) and 3–7 years’ PM experience in service or repair, with strong CAPA and regulatory knowledge and excellent communication.

Qualifications

• Bachelor’s degree in Business, Engineering, Construction Management, Operations Management, or related field.
• 3-7 years’ project management experience in service, repair, maintenance, construction, or field service operations.
• Proven track record managing CAPAs, lifecycle projects, and regulatory compliance activities.
• Strong understanding of design controls, risk management, and regulatory requirements (FDA, ISO).
• 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.
• Proficiency in project management tools, MS Office Suite, and project budgeting/forecasting.
• Willingness to travel up to 10% as needed (project-dependent).

Responsibilities

• Lead cross-functional projects focused on ongoing support and enhancement, including operations scaling, CAPAs, and process improvements.
• CAPA management: root cause analysis, corrective/preventive actions, and verification activities.
• Lifecycle projects: component replacements, redesigns, and system upgrades to extend product life and maintain regulatory compliance.
• Regulatory and compliance support: adhere to FDA, ISO, and other standards; prepare documentation for audits.
• Risk management: identify technical and operational risks and develop mitigation plans.
• Collaborate with R&D, Quality, Reg, Cyber, Supply chain, Service and MFG to influence design and processes for quality and cost efficiency.
• Develop detailed project plans, milestones, and timelines for sustaining activities.
• Maintain comprehensive records of project activities and regulatory documentation.

Skills

Project management

CAPA management

Lifecycle projects

Regulatory compliance

Cross-functional leadership

Communication

Budgeting

MS Office

Education

Bachelor's degree in Business

Bachelor's degree in Engineering

Bachelor's degree in Construction Management

Bachelor's degree in Operations Management

Equivalent experience

Tools

MS Office Suite

Job description

Johnson & Johnson in Danvers, MA is seeking a Project Manager, Service & Repair to lead cross-functional initiatives in cardiovascular care. You will ensure projects are delivered safely, on time, and in line with quality, regulatory, and operational standards.

The role requires a bachelor’s degree (Business/Engineering/Construction/Operations) and 3–7 years’ PM experience in service or repair, with strong CAPA and regulatory knowledge and excellent communication.