Manufacturing Engineer II

Job Description

Job Description

Description:

JOB TITLE:

Manufacturing Engineer II

REPORTS TO:

Manufacturing Engineering Manager

JOB TYPE:

Full-time, exempt

Job Summary

INTEGRA Biosciences Corporation is an industry leader in innovative liquid handling products for medical diagnostics, pharmaceutical, biotech, and food industries. 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.

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 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.

This job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. The company reserves the right to revise the job description at any time. The employee must be able to perform the position's primary functions satisfactorily and, if requested, reasonable accommodations may be made to enable employees with disabilities to perform the primary functions of their job, absent undue hardship.

INTEGRA Biosciences US is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, gender, national origin, disability, protected Veteran status, uniform service, sexual orientation, gender identity, gender expression, genetic information, or any other characteristic protected by law.