Manufacturing Engineer

Position Summary

The Manufacturing Engineer is responsible for developing, implementing, validating, and optimizing manufacturing processes for electronic, mechanical assembly and fabrication operations. This role supports new product introduction (NPI), process development, and continuous improvement initiatives to enhance productivity, product quality, worker safety, and cost efficiency. The Manufacturing Engineer provides technical leadership and hands-on support to manufacturing operations through process control, production line designs, root cause analysis, tooling and fixture development, automation projects, and compliance with quality management systems. Working cross-functionally with engineering, quality, supply chain, and production teams, this position ensures robust, scalable, and efficient manufacturing processes that support business objectives and customer requirements.

Job Duties & Responsibilities

• Analyze and optimize manufacturing processes to improve production efficiency, quality, safety, and cost performance.
• Develop, document, validate, and maintain manufacturing procedures, work instructions, process flows, and engineering documentation.
• Lead continuous improvement initiatives utilizing Lean Manufacturing, Six Sigma, Kaizen, 5S, SPC, and other operational excellence methodologies.
• Perform root cause analysis, failure investigations, and implement corrective and preventive actions (CAPA) to resolve manufacturing and quality issues.
• Design, develop, and implement manufacturing fixtures, tooling, and assembly processes for electronics and mechanical assemblies.
• Collaborate with production, quality, supply chain, engineering, vendors, and customers to resolve technical issues and improve manufacturing performance.
• Establish process controls, collect and analyze production data, develop labor standards, and monitor key manufacturing metrics.
• Support installation, qualification, and validation of new manufacturing equipment and capital projects.
• Lead new product introduction (NPI) activities, ensuring successful transfer of products from design into production.
• Develop and maintain APQP documentation including Process Flow Diagrams (PFD), PFMEA, Control Plans, MSA studies, and process validation protocols.
• Conduct capability studies and equipment/process qualifications including IQ, OQ, and PQ activities.
• Support compliance with ISO 9001, ISO 13485, and applicable regulatory requirements.
• Identify and implement automation solutions to improve manufacturing throughput, consistency, and product quality.

Qualifications

• Minimum 5 years of Manufacturing Engineering experience in a production environment.
• Medical device manufacturing experience preferred.
• Experience supporting mixed electrical and mechanical assembly.
• Hands-on experience with processes including soldering, epoxy application, tooling, fixtures and manufacturing equipment.
• Experience with process validation, process control and manufacturing documentation systems.
• Proven success leading continuous improvement and cost reduction initiatives.
• Experience supporting high-volume manufacturing environments preferred.
• This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR).
• This position requires individuals who are U.S. persons or protected individuals within the meaning of ITAR.
• ITAR defines U.S. persons and protected individuals as a U.S. Citizen, U.S. Permanent Resident (i.e., 'Green Card Holder'), U.S. Temporary Resident, Political Asylee, or Refugee.
• Skills: Lean Manufacturing and Six Sigma methodologies, APQP, PFMEA, Control Plans, SPC, MSA, CAPA, and Root Cause Analysis, Process validation methodologies including IQ/OQ/PQ preferred, Manufacturing automation and equipment integration, ERP/MPR systems and production planning tools, CAD software experience; SolidWorks preferred, Statistical analysis and process capability evaluation, Microsoft Office Suite proficiency, Strong problem-solving capabilities, Proficient in English (reading, writing & verbal skills), Effective interpersonal skills to drive tasks to completion.
• Education: Bachelor of Science in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related technical discipline. Equivalent combination of education and relevant engineering experience will be considered.

Environmental & Physical Requirements

• Manufacturing / Non-Sedentary Requirements: Incumbent must be able to perform the essential functions of the job. Work may be performed in an office or warehouse environment. Typically requires the ability to spend 66%+ hours each work day doing the following activities: stand for extended periods of time, walk, bend, stoop, or climb. May have possible exposure to dust, and may require the ability to lift and/or push up to 50 pounds 33% - 66% of the time.