Job Type
Full-time
Description
On-site • Hudson, NH
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.
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.
