Technical Project Manager - Medical Device
Job in
Olde West Chester, West Chester Township, Butler County, Ohio, USA
Listed on 2026-10-17
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-10-17
Job specializations:
-
Engineering
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Rate: $65-$70/hr on W2 (Negotiable based on experience)
Description:Our client is seeking a Technical Project Manager to lead Life Cycle Management (LCM) projects for existing finished goods, working with external manufacturing partners to ensure timely execution, quality compliance, and alignment with business objectives.
Responsibilities:- Lead LCM projects, managing project scope, timelines, technical feasibility, and business objectives.
- Provide technical oversight to external manufacturing partners and drive project implementation.
- Collaborate with Quality, R&D, Regulatory Affairs, Sourcing, Planning, and Operations teams.
- Manage change controls, technical documentation, and project activities using PLM systems such as Windchill.
- Identify technical and operational risks, resolve issues, and maintain supply chain and customer service commitments.
- Review and approve engineering drawings, manufacturing process documentation, IQ/OQ/PQ protocols, qualification reports, and validation activities.
- Ensure compliance with quality systems, regulatory requirements, and business priorities.
- Experience managing technical projects and Life Cycle Management (LCM) initiatives.
- Experience working with external manufacturing partners and cross-functional teams.
- Knowledge of change control, PLM systems (Windchill), and technical documentation.
- Experience with IQ/OQ/PQ, process qualification, and validation activities.
- Ability to review engineering drawings and manufacturing process documentation.
- Strong project management, risk assessment, problem-solving, and communication skills.
- Understanding of quality systems and regulatory requirements.
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