Project Manager

MTD Micro Molding • Full-time • Charlton, Massachusetts, United States • $90,000 - $110,000 / year • 1w ago

MTD Micro Molding manufactures minimally invasive medical and healthtech devices, from overmolded components to bioabsorbable implants. We help customers develop highly complex products that demand precision, technical problem-solving, and reliable execution.

We are seeking an experienced Project Manager to lead customer programs from development through production in a regulated medical manufacturing environment.

This is not an entry-level project management role. We are looking for someone who already has experience managing technical manufacturing projects independently and can confidently operate within ISO 13485-regulated processes.

The ideal candidate understands validation, technical documentation, statistical analysis, and cross-functional manufacturing coordination—and can keep complex programs moving without requiring extensive oversight or training.

What You’ll Be Responsible For

Managing customer programs from prototype through production launch
Coordinating timelines, deliverables, technical communication, and project execution across internal teams
Leading projects involving molding, tooling, automation, validation, and manufacturing operations
Managing validation-related activities including IQ/OQ/PQ coordination, protocol development, execution support, and report review
Supporting process development, revalidation, and engineering change activities
Working with Quality and Engineering teams to review data, troubleshoot issues, and support resolution activities
Maintaining project schedules and tracking milestones using Microsoft Project or similar timeline management tools
Communicating directly with customers regarding technical requirements, risks, schedules, and deliverables
Ensuring project documentation aligns with ISO 13485 and regulated manufacturing requirements
Managing multiple complex projects simultaneously while maintaining attention to detail and accountability

What Makes Someone Successful in This Role

This role is best suited for someone who is highly organized, technically capable, and comfortable working independently in a fast-paced manufacturing environment.

You should be able to proactively drive projects forward, identify risks early, coordinate cross-functional teams, and maintain momentum without requiring constant direction.

We are looking for someone who brings both project management discipline and technical understanding to the role.

Required Qualifications

3+ years of project management experience in medical device manufacturing or another regulated manufacturing environment
Working knowledge of ISO 13485 quality systems
Experience supporting validation activities and regulated documentation
Experience developing or coordinating protocols and technical reports
Experience with statistical analysis and data interpretation (MiniTab preferred)
Experience using Microsoft Project or similar scheduling/timeline management tools
Strong communication and organizational skills
Ability to interpret technical drawings, specifications, and manufacturing data
Ability to manage multiple projects independently with a high level of accountability

Preferred Qualifications