Manufacturing Engineer II

Integra-Bioscience; Hudson (NH); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

FSA Program

Paid Time Off

Paid Holidays

401(k) with company match

Job summary

INTEGRA Biosciences Corporation is seeking an experienced Manufacturing Engineer II in Hudson, NH to drive process and equipment improvements, support new product introductions, and lead cross‑functional problem solving. The role focuses on robust, documented, and sustainable manufacturing processes with mentoring for technicians and operators.

The candidate should have 5+ years in regulated/high‑volume manufacturing, strong skills in MES/SPC, injection molding, and fixture/tooling design, plus

Qualifications

• 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.
• Working knowledge of injection molding processes and manufacturing automation; cleanroom experience is a plus.
• Experience with assembly automation, machine vision inspection systems, MES, traceability systems, and SPC.
• Ability to design, develop, or specify fixtures and tooling; proficiency in SolidWorks and practical knowledge of machining and fabrication processes.

Responsibilities

• Investigate manufacturing and quality issues, perform root cause analysis, and implement CAPA as needed.
• Develop, optimize, and sustain manufacturing processes to improve safety, quality, yield, throughput, and OEE.
• Lead or support manufacturing start‑up activities for new product introductions and process changes.
• Specify, procure, install, and qualify new manufacturing equipment and automation systems; coordinate FAT/SAT, validation, and transfer to production.
• Create and maintain manufacturing documentation, including work instructions, standard work, training materials, and PFMEA inputs.
• Support ECOs and product transfers from R&D to Manufacturing; provide DFM recommendations and participate in design reviews.
• Provide hands‑on engineering support to production by troubleshooting equipment, processes, tooling, and automation systems; collaborate on preventive maintenance.
• Serve as a technical resource and mentor for technicians; foster continuous improvement.
• Lead and support safety, ergonomics, and environmental compliance initiatives.

Skills

Root Cause Analysis

CAPA

DOE

Lean Manufacturing

Six Sigma

SolidWorks

Gage R&R

Machine Vision

Education

Bachelors in Engineering

Tools

SolidWorks

Job description

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.

Primary Responsibilities

• 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.

Qualifications & 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 SolidWorks 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 ability to manage multiple priorities in a fast‑paced manufacturing environment with a high degree of ownership, accountability, and initiative.

Location and eligibility requirements

• This role is based in Hudson, NH. Please note that relocation assistance is not provided. Applicants must be authorized to work in the United States without current or future sponsorship.

Benefits

At Integra Biosciences, we invest in our employees' health, well-being, and future. Our comprehensive benefits package includes medical, dental, and vision insurance, FSA program, generous paid time off, paid holidays, and a 401(k)-retirement plan with company match. Plus, you'll enjoy additional benefits designed to help you thrive both professionally and personally.

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.