Technical Project Manager - Medical Device

Intellectt Inc

West Chester, Butler County, OH

Role: Technical Project Manager

Location: West Chester, OH

Duration: 12 Months - Onsite

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.

Required Skills:

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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Vacancy posted 11 hours ago

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