Project Manager, Engineering

Stryker•Mahwah, NJ

4d•Hybrid

About The Position

The MIM Project Manager will lead strategic projects to implement Metal Injection Molding (MIM) technology within Advanced Operations for medical device manufacturing. This role ensures seamless integration of MIM processes into production, supporting scalability, compliance, and cost efficiency. You will work across multiple manufacturing sites and collaborate closely with R&D, Manufacturing, Quality, Regulatory, and Supply Chain to deliver projects that meet medical device standards and timelines.

Requirements

Bachelor’s degree in Engineering or STEM related field
4+ years of project management experience in medical device or another regulated industry

Nice To Haves

PMP or equivalent certification
Strong knowledge of MIM processes and tooling
Experience with process validation and regulatory compliance (FDA, ISO 13485)

Responsibilities

Project Leadership & Execution: Lead MIM programs from concept through commercialization, ensuring alignment with business, technical, and regulatory requirements.
Develop project charters, work breakdown structures, schedules, and detailed Gantt charts; manage critical path and major workstreams.
Manage project budgets, track expenditures, and provide regular updates to stakeholders and leadership.
Identify and mitigate project risks; develop and monitor risk response plans.
Coordinate resource planning, role assignments, deliverables, and performance feedback with functional leaders.
Develop and execute stakeholder and communications management plans.
Prepare and present project status, risks, and recommendations to leadership.
Cross-Functional & Technical Collaboration: Collaborate with R&D, Manufacturing, Quality, Supply Chain, and external suppliers throughout the project lifecycle.
Support validation activities (IQ/OQ/PQ), process readiness, and design transfer for MIM components.
Provide guidance on MIM processes, tooling, materials, and manufacturability considerations.
Ensure compliance with FDA, ISO 13485, and internal quality system requirements.
Maintain required project documentation, including DHF and DMR content.
Operational Excellence: Identify opportunities to reduce cost, improve efficiency, and enhance quality within MIM integration projects.
Build strong working relationships across functions and external partners.
Exercise sound judgment and decision-making in ambiguous or fast-paced environments.
Incorporate end-user and stakeholder feedback to refine scope and ensure successful delivery.
Promote continuous learning, adaptability, and a customer-first mindset.