Manufacturing Engineer II

Primary Responsibilities

• Investigate manufacturing and quality issues; perform root cause analysis and implement corrective and preventive actions (CAPA) where applicable.
• Develop, improve, and sustain manufacturing processes to improve safety, quality, yield, throughput, and overall equipment effectiveness (OEE); verify improvements with data.
• Lead or support manufacturing start-up activities for new products and process changes, including line readiness, capacity planning inputs, and ramp support.
• Specify, procure, and qualify new equipment and automation; coordinate internal and external resources for build, installation, FAT/SAT, validation/qualification, and handoff to production.
• Create and maintain process documentation (work instructions, PFMEA/control plan inputs, standard work, training materials) and ensure effective operator/technician training.
• Support Engineering Change Orders (ECO) and product transfers from R&D to Manufacturing; provide Design for Manufacturability (DFM) feedback and participate in design reviews.
• Provide engineering support to production as needed, including troubleshooting equipment, tooling, and process variation; coordinate maintenance plans and spare parts strategy.
• Provide technical leadership and mentorship to technicians, operators, and molding/automation personnel; contribute to a culture of continuous improvement.
• Facilitate and support safety, environmental, and ergonomics initiatives; ensure changes are implemented in compliance with site and regulatory requirements.

Qualifications and Requirements

• B.S. degree in Mechanical, Industrial, Manufacturing, or Plastics Engineering (or equivalent).
• 5+ years of manufacturing engineering experience in a regulated or high-volume production environment (medical device, pharma/biotech, diagnostics, automotive, or similar preferred).
• Working knowledge of injection molding processes and automation; cleanroom experience preferred.
• Experience with assembly automation, vision inspection, and/or data collection systems (MES, traceability, SPC).
• Ability to design or specify fixtures and tooling; SolidWorks proficiency and practical understanding of machine shop/fabrication practices.
• Proficiency with structured problem-solving and statistical methods (e.g., DOE, capability, GR&R); Lean / Six Sigma Green Belt preferred.
• Strong written and verbal communication skills with the ability to collaborate across Engineering, Quality, Supply Chain, and Operations.
• Ability to manage multiple priorities in a fast-paced environment; demonstrated ownership and follow-through with limited supervision.