Project Manager

Job Title : Project Manager (Medical Device Industry)

Employment Type : W2 role no C2C

Job Overview :

We are seeking a skilled and experienced Project Manager with 6 years of experience in the medical device industry to lead and manage product development, regulatory compliance, and cross-functional project teams.

The ideal candidate will ensure that medical device projects are completed on time, within scope, and meet regulatory and quality requirements, including FDA, ISO, and EU MDR standards.

This role involves close collaboration with engineering, quality, regulatory, and manufacturing teams to deliver successful products from concept through commercialization.

Key Responsibilities :

• Lead and manage multiple medical device projects from initiation through product launch, ensuring adherence to project timelines, budgets, and quality standards.
• Develop detailed project plans, including scope, schedule, resource allocation, and risk management strategies.
• Oversee project execution, including design control, validation, verification, and regulatory submissions in accordance with FDA and ISO 13485 standards.
• Coordinate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and Marketing to ensure alignment with project objectives.
• Manage project documentation, including Design History Files (DHF), Risk Management Files, and project reports .
• Facilitate regular project meetings, communicate project status, risks, and issues to stakeholders, and drive decisions to resolve roadblocks.
• Ensure projects comply with regulatory requirements, such as FDA 21 CFR Part 820, ISO 13485, and EU MDR .
• Conduct risk assessments and Failure Modes and Effects Analysis (FMEA) to proactively identify and mitigate potential project risks.
• Support regulatory submissions for new products and design changes, ensuring all documentation is complete and accurate.
• Lead change management processes to control project scope, budget, and timelines.
• Support product validation, testing, and quality assurance activities, ensuring devices meet safety and efficacy standards.
• Maintain close communication with senior management, providing regular updates on project progress, risks, and financial status.

Qualifications :

• Bachelor’s degree in Engineering, Project Management, or a related field.
• 6 years of experience managing projects in the medical device industry .
• Strong knowledge of FDA regulations, ISO 13485, and EU MDR requirements for medical device product development.
• Experience managing product development projects, including design control, regulatory submissions, and manufacturing .
• Proven ability to manage cross-functional teams and communicate effectively with diverse stakeholders.
• Excellent problem-solving and decision-making skills, with the ability to manage risks and make timely decisions.
• Proficient in project management tools such as MS Project, Smartsheet, or equivalent .
• Strong understanding of risk management principles, including FMEA and CAPA .
• Excellent organizational, time management, and communication skills, with the ability to prioritize tasks and work under pressure.

Preferred Skills :

• PMP certification or equivalent project management training.
• Experience with Agile methodologies and Lean Six Sigma for process improvement.
• Familiarity with UDI (Unique Device Identification) and post-market surveillance .
1 hour ago