We are seeking a hands-on, results-driven Manufacturing Engineer to support the seamless transition of new products 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 and a continuous improvement mindset.

Key Responsibilities

• Project Leadership
  • Lead manufacturing engineering activities for new product introductions (NPI), 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.
• 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.
• Tooling & Equipment Management
  • Oversee the specification, procurement, and validation of molds, jigs, fixtures, and custom equipment.
  • Collaborate with toolroom personnel and external vendors to manage tooling performance, modifications, and preventative maintenance.
• 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.
• Compliance & Validation
  • Develop and execute validation protocols (IQ/OQ/PQ) in alignment with FDA, ISO 13485, and GMP requirements.
  • Ensure all processes meet regulatory standards and are audit-ready at all times.
• Cross-Functional Collaboration
  • Partner with Program Management, Quality, Operations, and Supply Chain to ensure design for manufacturability (DFM), smooth tech transfers, and issue resolution.
  • Facilitate manufacturing readiness reviews and support customer communications as needed.
• Continuous Improvement
  • Drive Kaizen initiatives, lead root cause investigations, and implement sustainable corrective and preventive actions (CAPA).
  • Identify and execute cost reduction and efficiency improvement projects without compromising quality or compliance.

Qualifications

• Education:
  • Bachelor's degree in Manufacturing, Mechanical, Industrial Engineering, or related discipline.
• Experience:
  • 2-5 years of experience in a manufacturing engineering or process development role, preferably in medical device, injection molding, or other regulated industries.
• Technical Proficiency:
  • Strong understanding of injection molding processes, mold qualification, and downstream assembly operations (e.g., ultrasonic welding, pad printing, packaging).
  • Hands-on experience with tooling design, procurement, and maintenance.
  • Proficient in process validation methodologies (IQ/OQ/PQ).
  • Skilled in statistical analysis tools (e.g., Minitab, Gainseeker) and process monitoring.
  • 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 is a plus.
  • High sense of urgency, ownership, and adaptability.

Work Environment & Physical Requirements

• Work is 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.