Manufacturing 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 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 LeadershipEquipment 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 DesignOptimization

• 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.

ToolingEquipment 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.

CleanroomFacility 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.

DocumentationTraining

• 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.

ComplianceValidation

• 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 EnvironmentPhysical 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.