Job 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 to driving process excellence, ensuring compliance, and enabling scalable, cost-effective manufacturing.
The ideal candidate will combine strong technical expertise with practical project execution skills, a continuous improvement mindset, and the ability to manage product and equipment transfers, validations, work instructions, and machine setup.
Key Responsibilities 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.
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 a fast-paced environment.
Work Environment & Physical Requirements - Work performed in both office and production/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 travel for equipment transfers, validations, and site support.
Job Tags
Full time, Work at office, Relocation,