Medical Device Project Lead West Lancaster - PA - Pennsylvania

Please strictly adhere to the following resume naming convention:

Must Have TechnicalFunctional Skills

A degree level or similar qualification experience in manufacturing engineering in orthopedics (metal

implants) that can lead lifecycle management technical projects with our external manufacturing

partners and suppliers.

Minimum 5 years of hands-on experience in medical device quality systems in various operational tasks of

quality systems

Knowledgeable in medical device FDA, MDD and MDR GMP requirements.

Experience leading cross-functional teams is required

The candidate will need to be an effective communicator, capable of working with both external partners

with external partners and internal cross functions, facilitating discussions, and navigating through

challenges. Ideally, this individual would serve as both a project lead and technical lead.

Roles & Responsibilities

Lead and execute technical Life Cycle Management (LCM) projects for existing finished goods in collaboration

with external manufacturing partners ensuring projects are completed on schedule, within scope, and in

accordance with business objectives.

Provide technical oversight and project leadership for external manufacturing partners. Assess and develop

project scope, business case and technical feasibility and ensure effective implementation in alignment with

business, quality, and regulatory requirements.

Utilize business and quality systems, including PLM (Windchill), to manage documentation, change controls,

and project-related activities.

Partner with and lead with cross functional teams including Quality, Research & Development, Regulatory

Affairs, Source, Plan, and Operations to execute supply chain priorities, change requests and project

deliverables.

Facilitate collaboration between internal stakeholders and external partners, proactively resolve issues, mitigate technical and operations risks, and maintain customer service commitments. Review and approve technical documentation, including engineering drawings, manufacturing process documentation, IQOQPQ protocols, qualification reports, and validation activities for new and existing processes, equipment, and systems. Manage Asset Decommissioning disposal requests with external manufacturing partner and coordinate disposition activities needed with internal business partners.

Generic Managerial Skills, If any

Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English

language.

Employee must be able to effectively prioritize and manage multiple activities and responsibilities.

Ability to function in a team environment and deliver on team objectives is required.

Ability to make decisions and solve problems while exhibiting situational judgement.

Experience leading projects, cross-functional team is required

Role Descriptions: Lead and execute technical Life Cycle Management (LCM) projects for existing finished goods in collaboration with external manufacturing partners ensuring projects are completed on schedule, within scope, and in accordance with business objectives. Provide technical oversight and project leadership for external manufacturing partners. Assess and develop project scope, business case and technical feasibility and ensure effective implementation in alignment with business, quality, and regulatory requirements. Utilize business and quality systems, including PLM (Windchill), to manage documentation, change controls, and project-related activities. Partner with and lead with cross functional teams including Quality, Research & Development, Regulatory Affairs, Source, Plan, and Operations to execute supply chain priorities, change requests and project deliverables. Facilitate collaboration between internal stakeholders and external partners, proactively resolve issues, mitigate technical and operations risks, and maintain customer service commitments. Review and approve technical documentation, including engineering drawings, manufacturing process documentation, IQOQPQ protocols, qualification reports, and validation activities for new and existing processes, equipment, and systems. Manage Asset Decommissioning disposal requests with external manufacturing partner and coordinate disposition activities needed with internal business partners.

Essential Skills: Manufacturing LCM Engineer

Desirable Skills:

Keyword:

Skills: EIS : Manufacturing Engineering Support

Experience Required: 6-8