About INTEGRA Biosciences

INTEGRA Biosciences is a global leader in innovative liquid handling solutions serving the medical diagnostics, pharmaceutical, biotech, and food industries. We are committed to precision, quality, and empowering laboratories worldwide.

Position Summary

The Manufacturing Engineer II supports and leads process and equipment improvements that increase safety, quality, productivity, and cost competitiveness. This role drives day-to-day manufacturing engineering activities, coordinates start-up efforts for new product launches, and partners cross-functionally to resolve technical issues using data-driven problem solving. The Manufacturing Engineer II works with limited supervision, provides technical guidance to technicians and operators, and ensures processes are qualified, documented, and sustained through robust work instructions, training, and preventive maintenance.

Key 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

• 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.

What We Offer

• Competitive compensation and benefits package
• Career growth within a global, innovative organization
• Supportive team environment with ongoing training