Confidential Search – Medical Device Manufacturing
About the Role
A leading precision manufacturing organization is seeking a Project Engineer / Project Manager professional to support customer programs, tooling initiatives, manufacturing improvements, and quality system requirements. This role will serve as a key technical liaison between customers, suppliers, engineering, manufacturing, and quality teams to ensure successful execution of projects from initial concept through production launch.
The ideal candidate will have experience managing engineering projects, supporting injection molding operations, reviewing tooling designs, driving continuous improvement initiatives, and ensuring compliance with medical device manufacturing standards, including ISO 13485 requirements.
This position requires strong communication skills, technical expertise, and the ability to manage multiple projects while maintaining customer satisfaction and operational excellence.
Key Responsibilities
- Serve as the primary point of contact for customer communication regarding project status, timelines, delivery requirements, and qualification activities.
- Manage customer projects from initial tooling and product development through production realization.
- Coordinate and facilitate new mold construction projects to ensure schedules, quality objectives, and customer expectations are achieved.
- Review mold and tooling designs to improve manufacturability, quality, and production outcomes.
- Perform Design for Manufacturability (DFM) reviews for new product opportunities.
- Review and manage engineering changes, tooling modifications, gauges, fixtures, and jigs.
- Lead project meetings with customers and internal teams to communicate status, risks, and action plans.
- Prepare technical documentation and support quotation packages.
- Manage qualification projects in collaboration with Quality Assurance teams.
- Support implementation of manufacturing and engineering programs designed to improve operational performance.
- Assist with equipment selection, implementation, and facility improvement initiatives.
- Provide technical input regarding project costs, feasibility, tooling requirements, and manufacturing processes.
- Support molding operations through timely coordination of materials, supplies, and components.
- Drive continuous improvement initiatives across molding, tooling, printing, and manufacturing operations.
- Support implementation and maintenance of company quality objectives, including compliance with ISO 13485:2016 and applicable industry standards.
- Promote safe work practices and support compliance with OSHA requirements.
Required Qualifications
- Bachelor’s degree in Engineering or related technical discipline.
- Proficiency with Microsoft Office applications, including Excel, Word, Project, and Outlook.
- Strong project management and organizational skills.
- Ability to effectively communicate with customers, suppliers, and cross-functional teams.
Preferred Qualifications
- Experience in a manufacturing or engineering environment.
- Experience with precision injection molding processes and tooling.
- Knowledge of plastic injection molding applications for medical devices.
- Experience supporting medical device manufacturing and qualification processes.
- Experience with quality systems and ISO 13485 requirements.
- Strong understanding of safety procedures and OSHA practices.
- Project management experience from concept through production launch.
- Experience with cost analysis and manufacturing feasibility reviews.
- SOLIDWORKS proficiency.
- Spanish speaking, reading, and writing ability is a plus.
Core Skills
- Project Management
- Manufacturing Engineering
- Tool Design & Mold Construction
- Plastic Injection Molding
- Medical Device Manufacturing
- Design Reviews
- Design for Manufacturability (DFM)
- Quality Management Systems
- ISO 13485 Compliance
- Qualification Management
- Process Engineering
- Cost Analysis
- Equipment Implementation
- Continuous Improvement
- Customer & Supplier Communication
- SOLIDWORKS
- Microsoft Office Suite
Please send all resumes to sabrina.pike@gogpac.com. Only applications with a resume will be considered. Applicants must be able to confirm their eligibility and authorization to live and work in the location specified for this position.
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
