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Manufacturing Engineer

Finish Line Staffing Services

Mansfield, MA

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JOB DETAILS
SKILLS
Assembly Equipment, Assembly Line, AutoCAD, Automation, CAD (Computer-Aided Design) Software, Calibration, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cost Control, Cost Effectiveness Analysis, Creo Elements/Pro, Cross-Functional, Electromechanical Assembly, Engineering, Equipment Validation, FDA (Food and Drug Administration), FDA Requirements, Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Lean Manufacturing, Maintain Compliance, Manufacturing, Manufacturing Design, Manufacturing Engineering, Manufacturing Equipment, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, Medical Products, Network Routers, Operational Improvement, Operational Strategy, Operations Processes, Organizational Skills, Preventative Maintenance, Process Development, Process Failure Mode and Effects Analysis (PFMEA), Process Flow Diagram (PFD), Process Improvement, Process Validation, Product Design, Production Support, Project/Program Management, Quality Engineering, Quality System Requirements (QSR), Research & Development (R&D), Risk Management, Safety/Work Safety, Six Sigma Black Belt, Six Sigma Certification, SolidWorks, Staff Training, Standard Operating Procedures (SOP), Technical/Engineering Design, Test Equipment, Time Management, Tool and Die Manufacturing, Validation Plan
LOCATION
Mansfield, MA
POSTED
1 day ago
Our client is seeking a Manufacturing Engineer to support the development, implementation, and continuous improvement of manufacturing processes within a regulated medical device environment. This role will work closely with Engineering, Quality, Operations, and R&D teams to successfully transition products into manufacturing, optimize production processes, and drive operational excellence through lean manufacturing principles.The ideal candidate will have experience in medical device manufacturing, process validation, equipment development, and continuous improvement initiatives.

Key Responsibilities

  • Design, develop, implement, and maintain manufacturing processes for medical device production.
  • Create and maintain:
    • Process Failure Mode and Effects Analysis (PFMEA)
    • Process Flow Diagrams
    • Manufacturing cell and line layouts
    • Process routers
    • Standard Operating Procedures (SOPs)
    • Work Instructions
    • Validation protocols and reports
  • Specify manufacturing equipment, tooling, and process requirements.
  • Perform equipment qualifications and process validations, including IQ, OQ, and PQ activities.
  • Develop, validate, and implement automated, semi-automated, and manual assembly and test equipment.
  • Ensure manufacturing equipment and tooling are properly documented and maintained through calibration and preventive maintenance programs.
  • Participate in FMEA activities to identify and mitigate manufacturing process risks.
  • Collaborate with Design Engineering and Quality teams to ensure products are designed for manufacturability, quality, and cost-effectiveness.
  • Support pilot production activities and develop lean manufacturing cells that optimize throughput, efficiency, and product quality.
  • Train production personnel on manufacturing processes, equipment, and work instructions.
  • Provide day-to-day manufacturing support and troubleshoot production issues.
  • Drive continuous improvement initiatives focused on safety, quality, productivity, lead time, and cost reduction.
  • Investigate manufacturing nonconformances using NCMR and CAPA methodologies and implement corrective and preventive actions.
  • Support and maintain compliance with FDA Quality System Regulations (QSR) and ISO 13485 requirements.

Qualifications

Required

  • Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Mechanical Engineering Technology, or a related discipline.
  • 5–8 years of manufacturing engineering experience, preferably within the medical device industry.
  • Experience with process development, validation, and equipment qualification activities.
  • Strong knowledge of manufacturing processes involving electromechanical components and assemblies.
  • Experience with 3D CAD software such as SolidWorks, AutoCAD, Pro/ENGINEER, or similar platforms.
  • Working knowledge of FDA GMP, QSR, and ISO 13485 requirements.
  • Proficiency with Microsoft Office applications.
  • Strong analytical, problem-solving, and troubleshooting skills.
  • Ability to work independently and collaboratively within cross-functional teams.
  • Self-motivated with strong organizational and project management abilities.

Preferred

  • Experience working in an FDA-regulated medical device manufacturing environment.
  • Six Sigma Black Belt certification.
  • Experience implementing lean manufacturing principles and continuous improvement programs.
  • Experience with automation, assembly equipment, and manufacturing process optimization.

Work Environment

  • Fast-paced manufacturing and engineering environment.
  • Frequent collaboration with Operations, Quality, Engineering, and R&D teams.
  • Hands-on involvement with manufacturing equipment, processes, and production operations.

Why Join?

This opportunity offers the chance to play a key role in bringing innovative medical products into production while driving process improvements, operational efficiency, and manufacturing excellence within a highly regulated and growing industry.

About the Company

F

Finish Line Staffing Services

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