Manufacturing Project Manager

Apollo Technical; Mooresville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Apollo Technical in Mooresville, NC is seeking a Manufacturing Project Manager to lead cross-functional programs from prototype through production scale-up in a regulated precision manufacturing environment.

You will partner with Engineering, Quality, Production, Supply Chain, and customers to ensure on-time, on-budget delivery, while driving continuous improvement in advanced CNC machining operations.

Qualifications

• Bachelor's degree in Engineering or related field; equivalent experience considered.
• 5+ years of project management in precision manufacturing, preferably medical devices.
• Strong knowledge of CNC machining processes, GD&T, and medical device workflows.
• Experience with ISO 13485 and/or FDA QSR quality systems.
• Proven ability to manage multiple concurrent projects and meet tight timelines.
• Excellent communication and stakeholder management skills.

Responsibilities

• Plan, execute, and close manufacturing projects from concept through full production.
• Coordinate cross-functional teams across Engineering, Quality, CNC, Tooling, Supply Chain, and Operations.
• Oversee production-level prototyping with 5-axis machining and Swiss turning.
• Develop and maintain project plans, Gantt charts, risk registers, and status reports.
• Ensure ISO 13485 and FDA 21 CFR Part 820 compliance; support FAI and change control.
• Drive cost containment and efficiency through lean manufacturing initiatives.
• Manage customer requirements including design transfers and VMI coordination.
• Identify and mitigate manufacturing risks related to tolerances and materials.
• Support new product introductions, capacity planning, and process improvements.
• Track KPIs and lead post-project reviews.

Skills

Project management

Cross-functional teamwork

Communication

Problem solving

MS Project

Smartsheet

GD&T

ISO 13485 knowledge

Education

Bachelor’s degree in Engineering or related technical field

Tools

MS Project

Smartsheet

ERP systems

Microsoft Office

Job description

Position Overview

The Manufacturing Project Manager will lead cross-functional projects that take new and existing medical implant, instrument, and cutting tool programs from prototype through production scale-up and ongoing manufacturing.

This role ensures on-time, on-budget, high-quality delivery while driving continuous improvement in our advanced CNC machining environment. You will partner closely with Engineering, Quality, Production, Supply Chain, and customers to support Structure Medical’s reputation as a tier-one supplier known for rapid response, production-level prototypes, and cost-effective precision manufacturing.

Key Responsibilities

• Plan, execute, and close manufacturing projects for spine, trauma, arthroscopic implants, instruments, and cutting tools, managing scope, schedule, budget, resources, and risks from concept/prototype through validation and full production.
• Coordinate cross-functional teams (Engineering, Quality Assurance, CNC Programming/Machining, Tooling, Supply Chain, and Operations) across facilities.
• Oversee production-level prototyping using the same advanced equipment (5-axis machining, Swiss turning, etc.) that will run production, minimizing inconsistencies between prototype and scale-up.
• Develop and maintain detailed project plans, Gantt charts, risk registers, and status reports; communicate progress, issues, and recovery plans to internal stakeholders and OEM customers.
• Ensure all projects comply with ISO 13485, FDA 21 CFR Part 820, and internal quality management systems; support First Article Inspections (FAI), process validations, and change control.
• Drive cost containment and efficiency by optimizing operations, reducing setup/lead times, and supporting continuous improvement initiatives (lean manufacturing principles).
• Manage customer requirements, including design transfers, specification reviews, and Vendor-Managed Inventory (VMI) coordination where applicable.
• Identify and mitigate manufacturing risks related to complex geometries, tight tolerances, materials and high-precision processes.
• Support new product introductions, capacity planning, and process improvements that leverage proprietary holding methods, laser tool management, and advanced machining protocols.
• Track key performance indicators (on-time delivery, quality metrics, cost variance) and lead post-project reviews to capture lessons learned.

Qualifications

Required

• Bachelor’s degree in Engineering (Mechanical, Manufacturing, Industrial, Biomedical), or related technical field; equivalent experience considered.
• 5+ years of project management experience in a precision manufacturing environment, preferably medical devices, or highly regulated machining.
• Strong knowledge of CNC machining processes (multi-axis milling/turning, Swiss-type, 5-axis), GD&T, and medical device manufacturing workflows is preferred
• Experience with quality systems (ISO 13485 and/or FDA QSR) and associated documentation (protocols, reports, change control) is preferred
• Proven ability to manage multiple concurrent projects, prioritize in a fast-paced production setting, and deliver results under tight timelines.
• Excellent communication, stakeholder management, and problem-solving skills; ability to work effectively with shop-floor teams and external OEM customers.
• Proficiency with project management tools (MS Project, Smartsheet, or equivalent), ERP systems, and Microsoft Office Suite.