Manufacturing Project Engineer

Manufacturing Project Engineer

We are seeking a hands-on, results-driven Manufacturing Project Engineer to support the seamless transition of new products and equipment from development into full-scale production within our regulated medical injection molding and assembly facility. This role is critical to driving process excellence, ensuring compliance, and enabling scalable, cost-effective manufacturing.

Project Leadership & Equipment Integration

Lead or support manufacturing engineering activities for new product introductions (NPI) and equipment integrations, from concept through validation and production ramp-up.
Manage project timelines, deliverables, and risk mitigation strategies to ensure on-time, in-spec, and in-budget launches.
Plan and coordinate the transfer of existing machines or installation of new equipment into the facility, ensuring proper setup, qualification, and documentation.
Coordinate cross-functional teams to ensure design for manufacturability (DFM) and smooth technology or equipment transfers.
Partner with Program Management, Quality, Operations, and Supply Chain to ensure process readiness and effective issue resolution.
Facilitate manufacturing readiness reviews and support customer communications as needed.

Process Design & Optimization

Develop, optimize, and scale injection molding and secondary assembly processes to ensure consistent quality, high efficiency, and cost-effectiveness.
Apply Lean principles, data analytics, and root cause methodologies (5-Whys, Fishbone, etc.) to eliminate waste and reduce variability.

Identify and execute cost reduction and efficiency improvement projects without compromising quality or compliance.

Tooling & Equipment Management

Oversee the specification, procurement, transfer, setup, and validation of molds, jigs, fixtures, and custom equipment.
Lead the installation and qualification of new or relocated machines and automation equipment to support production readiness.
Collaborate with toolroom personnel and external vendors to manage tooling performance, modifications, and preventative maintenance.
Support mold qualification and maintenance activities to ensure sustained performance and reliability.

Documentation & Training

Create and maintain robust documentation including process flow diagrams, work instructions, SOPs, and validation protocols.
Lead operator training and knowledge transfer for new or revised manufacturing processes.
Ensure all documentation is accurate, current, and compliant with regulatory and quality system requirements.

Compliance & Validation

Develop and execute process validation protocols (IQ/OQ/PQ) in alignment with FDA, ISO 13485, and GMP requirements.
Ensure all processes meet regulatory and quality standards and are audit-ready at all times.
Maintain alignment with ISO 9001, internal quality systems, and customer-specific requirements.

Cross-Functional Collaboration

Partner with Program Management, Quality, Operations, Supply Chain, and Tooling to ensure smooth product launches, equipment transfers, and process readiness.
Collaborate with cross-functional teams during design reviews, DFM assessments, and risk analyses.
Support customer communications and technical discussions related to manufacturability, validation, and production readiness.

Continuous Improvement

Drive Kaizen and continuous improvement initiatives across production and engineering functions.
Lead root cause investigations and implement sustainable Corrective and Preventive Actions (CAPA).
Utilize statistical tools and data-driven decision-making to improve process capability and reduce scrap.
Contribute to a culture of accountability, problem-solving, and innovation.

Qualifications

Education

Bachelor's degree in Manufacturing, Mechanical, Industrial, or related Engineering discipline.

Experience

3-7 years of experience in manufacturing engineering or process development, preferably in medical device injection molding or other regulated industries.

Technical Proficiency

Strong understanding of injection molding, mold qualification, and downstream assembly operations (e.g., ultrasonic welding, pad printing, packaging).
Hands-on experience with tooling design, equipment procurement, machine setup, transfers, and maintenance.
Proficient in process validation methodologies (IQ/OQ/PQ) and statistical analysis tools (Minitab, Gainseeker).
Skilled in process monitoring, data analytics, and root cause problem solving.
CAD experience required; simulation tools a plus.
In-depth knowledge of ISO 13485, ISO 9001, FDA, and GMP standards.

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.