Manufacturing Engineer

Job Description
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.

POSITION GUIDELINES
• 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.
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.
• 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.
Job Description
Manufacturing Engineer
Effective Date June 4, 2018
• 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
Experience/Background
• 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.
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.
• Manufacturing automation and equipment integration.
• ERP/MRP 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 disciplineJob Description
Manufacturing Engineer
Effective Date June 4, 2018
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.
POSITION GUIDELINES
• 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.
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.
• 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.
Job Description
Manufacturing Engineer
Effective Date June 4, 2018
• 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
Experience/Background
• 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.
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.
• Manufacturing automation and equipment integration.
• ERP/MRP 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