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.
