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Job DescriptionJob Description

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 for driving process excellence, scalable manufacturing, regulatory compliance, and cost-effective operations. The ideal candidate combines strong technical expertise, practical project execution skills, cleanroom experience, and a continuous improvement mindset to manage NPI product launches, equipment transfers, process validations, and cleanroom/building projects.

Key Responsibilities

Project Leadership & Equipment Integration

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

Process Design & Optimization

Develop, optimize, and scale injection molding and downstream assembly processes (e.g., ultrasonic welding, pad printing, packaging) for consistent quality, efficiency, and cost-effectiveness. Apply Lean principles, root cause analysis (5-Whys, Fishbone), and statistical tools to reduce waste, variability, and operational costs. Identify and implement process improvements and cost reduction initiatives without compromising quality or compliance.

Tooling & Equipment Management

Oversee the specification, procurement, installation, setup, validation, and maintenance of molds, jigs, fixtures, and custom equipment. Collaborate with toolroom personnel and external vendors to manage tooling performance, modifications, and preventative maintenance. Support mold qualification and equipment performance verification to ensure sustained reliability.

Cleanroom & Facility Projects

Serve as subject matter expert (SME) for cleanroom and controlled environments. Lead or support the design, build-out, and qualification of new cleanrooms, molding areas, and assembly areas. Ensure compliance with cleanroom classifications, gowning practices, material flow, and contamination controls. Conduct cleanroom qualification/requalification (IQ/OQ/PQ) and maintain environmental monitoring programs (particulates, temperature, humidity, differential pressure). Provide training for operators and staff on cleanroom procedures, contamination control, and safe operation practices.

Documentation & Training

Create and maintain process flow diagrams, work instructions, SOPs, validation protocols, and project documentation. Lead operator training and knowledge transfer for new or revised manufacturing processes. Ensure all documentation meets regulatory, customer, and quality system requirements.

Compliance & Validation

Develop and execute process validation protocols (IQ/OQ/PQ) in alignment with FDA, ISO 13485, GMP, and internal quality standards. Ensure all processes and equipment are audit-ready and meet regulatory compliance 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 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 Lean initiatives, leading root cause investigations and implementing sustainable Corrective and Preventive Actions (CAPA). Utilize statistical tools and data-driven decision-making to improve process capability, reduce scrap, and enhance efficiency. Contribute to a culture of accountability, problem-solving, and innovation across the manufacturing floor.

Qualifications

Education

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

Experience

3-7 years in manufacturing engineering, process development, or project engineering in medical device, injection molding, or other regulated industries. Demonstrated experience in NPI, equipment/machine transfers, process validation, and cleanroom/facility projects.

Technical Proficiency

Strong understanding of injection molding processes, mold qualification, and downstream assembly operations. Hands-on experience with tooling design, equipment procurement, machine setup, and transfers. Proficient in process validation methodologies (IQ/OQ/PQ) and statistical analysis tools (e.g., Minitab, GainSeeker). CAD experience required; simulation tools a plus. In-depth knowledge of ISO 13485, ISO 9001, FDA, GMP, and medical device standards.

Soft Skills

Strong project management and organizational abilities. Excellent problem-solving and analytical thinking. Effective communicator across functions and levels; customer-facing experience a plus. High sense of urgency, ownership, and adaptability in fast-paced environments.

Work Environment & Physical Requirements

Work performed in both office, production, and cleanroom environments. Must be able to stand, walk, and interact with manufacturing equipment daily. Ability to lift up to 25 lbs. Must adhere to cleanroom and safety protocols. Travel: up to 30% domestic for equipment transfers, validations, and site support.

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