Medical Device Project Manager: ISO 13485 & Micro Molding

About MTD Micro Molding

MTD Micro Molding manufactures highly engineered minimally invasive medical and healthtech devices, including precision overmolded components and bioabsorbable implants. We partner with innovative customers to develop complex products that require precision engineering, disciplined execution, and strong technical problem-solving within a regulated manufacturing environment.

Position Overview

We are seeking an experienced Project Manager to lead customer programs from development through production launch. This is a hands-on, technical project management role that requires prior experience independently managing manufacturing projects in a regulated industry.

Candidates should be comfortable operating within ISO 13485 quality systems and coordinating cross-functional engineering, quality, and manufacturing activities.

Key Responsibilities

The Project Manager will be responsible for driving programs involving injection molding, micro molding, tooling, automation, validation, and process development.

Key responsibilities include:

• Managing project schedules, deliverables, and milestones
• Coordinating cross-functional execution across Engineering, Quality, Manufacturing, and Tooling teams
• Communicating directly with customers regarding technical requirements, risks, schedules, and deliverables
• Supporting validation activities including IQ/OQ/PQ coordination, protocol development, execution support, and report review
• Supporting process development, revalidation efforts, and engineering change activities
• Ensuring alignment with ISO 13485 quality system and documentation requirements
• Managing multiple complex projects simultaneously in a fast-paced environment

What Success Looks Like

Success in this role requires someone who is highly organized, technically capable, and comfortable working independently.

The ideal candidate will:

• Proactively manage multiple technical projects with minimal oversight
• Identify risks early and maintain project momentum
• Coordinate effectively across engineering and manufacturing teams
• Interpret technical drawings, specifications, and manufacturing data
• Communicate clearly with both internal teams and external customers

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 technical documentation
• Experience developing or coordinating protocols and technical reports
• Experience with statistical analysis and data interpretation (Mini Tab preferred)
• Experience using Microsoft Project or similar scheduling tools
• Strong communication and organizational skills
• Ability to manage multiple complex projects independently

Preferred Qualifications

• Engineering degree or technical manufacturing background
• Experience with injection molding, micro molding, or automation
• Familiarity with ERP systems such as IQMS
• Experience with GR&R studies and statistical manufacturing analysis

Pay: $90,000.00 - $ per year

Why Join MTD?

• Competitive Salary ($90,000.00 - $ per year)
• Profit sharing
• 401(k) with company match
• Health insurance
• Opportunity to work on highly technical medical and healthtech products
• Exposure to advanced manufacturing and inspection technologies
• Collaborative, engineering-driven environment