Manufacturing Engineer II

Description

On-site Hudson, NH

INTEGRA Biosciences Corporation is a leading provider of innovative liquid handling solutions serving the medical diagnostics, pharmaceutical, biotechnology, and food industries. We are committed to advancing scientific discovery through high-quality products, continuous innovation, and operational excellence.

We are seeking a Manufacturing Engineer II, who will play a key role in driving process and equipment improvements that enhance safety, quality, productivity, and cost competitiveness across manufacturing operations. You will lead day-to-day manufacturing engineering activities, support new product introductions, and partner with cross-functional teams to resolve technical challenges through data-driven problem solving. Working with limited supervision, you will provide technical guidance to technicians and operators while ensuring manufacturing processes are robust, documented, qualified, and sustainable.

• Investigate manufacturing and quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA) as needed.
• Develop, optimize, and sustain manufacturing processes to improve safety, quality, yield, throughput, and overall equipment effectiveness (OEE), validating improvements through data analysis.
• Lead or support manufacturing start-up activities for new product introductions and process changes, including line readiness assessments, capacity planning, and production ramp-up support.
• Specify, procure, install, and qualify new manufacturing equipment and automation systems. Coordinate internal and external resources through design, build, FAT/SAT, validation, and transfer to production.
• Create and maintain manufacturing documentation, including work instructions, standard work, training materials, and PFMEA/control plan inputs.
• Support Engineering Change Orders (ECOs) and product transfers from R&D to Manufacturing. Provide Design for Manufacturability (DFM) recommendations and participate in design reviews.
• Provide hands‑on engineering support to production by troubleshooting equipment, processes, tooling, and automation systems. Collaborate with Maintenance to develop preventive maintenance plans and spare parts strategies.
• Serve as a technical resource and mentor for technicians, operators, and manufacturing personnel, fostering a culture of continuous improvement.
• Lead and support initiatives related to safety, ergonomics, and environmental compliance, ensuring all changes meet company and regulatory requirements.

• Bachelor's degree in mechanical, industrial, manufacturing, or plastics engineering, or a related technical discipline.
• Minimum of 5 years of manufacturing engineering experience in a regulated and/or high-volume production environment. Experience in medical device, diagnostics, pharmaceutical, biotechnology, or similar industries is preferred.
• Working knowledge of injection molding processes and manufacturing automation; cleanroom experience is a plus.
• Experience with assembly automation, machine vision inspection systems, Manufacturing Execution Systems (MES), traceability systems, and Statistical Process Control (SPC).
• Ability to design, develop, or specify fixtures and tooling; proficiency in Solid Works and practical knowledge of machining and fabrication processes.
• Strong understanding of structured problem‑solving methodologies and statistical tools, including DOE, process capability analysis, and GR&R. Lean Manufacturing and/or Six Sigma Green Belt certification preferred.
• Excellent written, verbal, and interpersonal communication skills with the ability to collaborate effectively across engineering, Q quality, supply chain, and operations teams.
• Proven…