Project Manager

Summary :
We are seeking an experienced Project Manager with a strong background in medical device component development and New Product Development (NPD). The ideal candidate will lead cross-functional project activities including planning, execution, testing, verification, validation, and manufacturing/line transfer while ensuring compliance with medical device regulations and internal change control processes.



Roles & Responsibilities :

• Lead and manage project management activities, including project planning, schedule development, tracking, and stakeholder communication.
• Collaborate with cross-functional teams (Engineering, Quality, Manufacturing, Supply Chain, Regulatory) to align on project plans, testing strategies, and execution.
• Coordinate across multiple projects to determine product configuration strategies, including defining which product versions will be tested.
• uthor, review, and drive activities such as component development, engineering builds, verification, and validation through the Ethicon Change Control System.
• Drive and manage manufacturing / line transfer activities, including tactical planning, logistics coordination, and risk mitigation.
• Coordinate with internal and external teams executing transfer activities across manufacturing sites.
• Perform root cause analysis, debugging, and troubleshooting for issues arising during or post-transfer.
• Critically review and approve test protocols, validation plans, and test reports.
• Support or lead additional Lifecycle Engineering (LCE) projects as required.
• Travel to manufacturing plants as needed to support project execution.

Education & Experience :

• 4-6 years of experience in Project Management within the medical device industry.
• Strong experience in medical device component development and New Product Development (NPD) methodologies.
• Solid understanding of medical device regulations (FDA, ISO 13485, QMS).
• Experience managing change control processes (ECR/ECO/ECN).
• Hands-on experience with verification, validation, and testing strategies.
• Strong analytical skills with experience in root cause analysis and problem solving.
• Excellent communication skills; must be highly proficient in reading, writing, and speaking English.
• bility to multitask, prioritize, and manage multiple activities simultaneously.
• Proven ability to understand and follow complex written procedures.
• Strong decision-making skills with sound situational judgment.
• bility to work effectively in a team-oriented, cross-functional environment.
• Experience with Windchill (PLM).
• Exposure to manufacturing or technology transfer projects.
• Prior experience supporting Lifecycle Engineering (LCE) initiatives.
• Strong organizational and leadership skills.
• bility to manage ambiguity and navigate obstacles in fast-paced environments.
• Customer-focused mindset with the ability to respond quickly and effectively to information requests.
• Proven ability to deliver results while aligning with team and organizational objectives.