Manufacturing Engineer

POSITION SUMMARY

The Manufacturing Engineer is responsible for developing, implementing, validating, and optimizing manufacturing processes for electronics and mechanical assembly 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, 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.

• Effective interpersonal and team leadership skills.
• Able to solve complex problems.
• Good verbal and written communication skills.
• Sound judgement and decision making.
• Ability to communicate and implement change.

• 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.
• Support assembly operations involving soldering, epoxy dispensing, electromechanical assembly, and related manufacturing processes.
• 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.

• Minimum 5 years of Manufacturing Engineering experience in a production environment.
• Medical device manufacturing experience required.
• Experience supporting mixed electronics and mechanical assembly manufacturing operations.
• Hands‑on experience with assembly 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.

• Lean Manufacturing and Six Sigma methodologies.
• APQP, PFMEA, Control Plans, SPC, MSA, CAPA, and Root Cause Analysis.
• Process validation methodologies including IQ/OQ/PQ.
• Manufacturing automation and equipment integration.
• ERP/MRP systems and production…