CX-1258 Manufacturing Engineer

Coghlin Companies Inc; West Boylston (MA); On-site; USD 75,000 - 90,000; Full time

Job summary

Cogmedix in West Boylston, MA is seeking a Manufacturing Engineer I to support ECO processes, drive 100% ECO implementation accuracy, and collaborate across departments to optimize production flow and BOM management. The role emphasizes training, compliance, and lean improvements, with a salary in the $75k–$90k range depending on experience.

Qualified candidates hold a Bachelor’s degree in Engineering and will engage with customers and suppliers while upholding Cogmedix Quality System standards

Qualifications

• Engineering degree required.

Responsibilities

• Support strict compliance adherence at Cogmedix.
• Train personnel, including customers and suppliers on workmanship and quality standards.
• Compliantly implement and maintain Cogmedix procedures.
• Collaborate with Program Managers, Manufacturing Engineers and other departments to analyze customer ECOs and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process.
• As part of the ECO process, support the management of the customer BOM structure, creation of part numbers and structuring of supplier relationships and costs.
• Define PP/PA/Phantom, commodity codes, documentation packages commodity and work instruction evaluation.
• As part of the ECO process, support the generation and updating of DMR indexes to ensure accuracy.
• Create complex ECOs.
• Ensure 100% ECO implementation accuracy.
• Ensure compliance to ECO implementation performance metrics goals.
• Effectively interact with customers and internal departments to create value-add propositions.
• Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements.
• Support internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs.
• Promptly respond to manufacturing floor issues, taking appropriate action within the Cogmedix Quality System and continually building strong rapport with customers and suppliers.
• Collaborate with Program Management, Quality, and Operations to develop and approve optimal work order routings and Device History Records.
• Preparation of redlined documentation for sign offs.
• Generate nonconformance documentation for approval and execution for production support.
• Support complex troubleshooting efforts. Generate rework instructions.
• Assist in the deployment of lean manufacturing cells.
• Train Assembly Technicians and Test Technicians on procedures as needed.
• ME support for Scaled Product Launch/transfers.
• Generate process validation/qualification documentation (e.g., validation protocols, IQ/OQ/PQ/PPQ) and implement protocols and completion of reports.
• Prepare process flows, assembly flow diagrams, PFMEAs, perform time studies, and participate in value stream mapping activities.
• Assist in the evaluation of product performance data and internal metrics for stability and continuous improvements, utilizing Six Sigma practices where appropriate.
• Generate Risk analyses, Risk management plans, and Risk reports.
• Lead or attend customer specific daily team meetings/challenge busters (as needed).
• Review new customer documentation packages.
• Lead, execute, and support co-build activities.
• Enroll equipment into the eQMS for assigned product accounts.
• Review and generate procedures for customer processes.
• Generate equipment and fixture updates or improvement ideas.
• Update procedures as needed.
• Perform other activities as directed.

Education

Bachelor's or higher in Engineering

Job description

Cogmedix
127 Hartwell Street
West Boylston, MA 01583, USA

Description

• Under the direction of the Senior Manufacturing Engineer or Manufacturing Engineer II, the Manufacturing Engineer I will (for the assigned product accounts):
  • Support strict compliance adherence at Cogmedix.
  • Train personnel, including customers and suppliers on workmanship and quality standards.
  • Compliantly implement and maintain Cogmedix procedures.
  • Collaborate with Program Managers, Manufacturing Engineers and other departments to analyze customer ECOs and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process.
  • As part of the ECO Process, support the management of the customer BOM structure, creation of part numbers and structuring of supplier relationships and costs. Define PP/PA/Phantom, commodity codes, documentation packages commodity and work instruction evaluation.
  • As part of the ECO process, support the generation and updating of DMR indexes to ensure accuracy.
  • Create complex ECOs.
  • Ensure 100% ECO implementation accuracy.
  • Ensure compliance to ECO implementation performance metrics goals.
  • Effectively interact with customers and internal departments to create value-add propositions.
  • Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements.
  • Support internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs.
  • Promptly respond to manufacturing floor issues, taking appropriate action within the Cogmedix Quality System and continually building strong rapport with customers and suppliers.
  • Collaborate with Program Management, Quality, and Operations to develop and approve optimal work order routings and Device History Records.
  • Preparation of redlined documentation for sign offs.
  • Generate nonconformance documentation for approval and execution for production support.
  • Support complex troubleshooting efforts. Generate rework instructions.
  • Assist in the deployment of lean manufacturing cells.
• Train Assembly Technicians and Test Technicians on procedures as needed.
• ME support for Scaled Product Launch/transfers.
• Generate process validation/qualification documentation (e.g., validation protocols, IQ/OQ/PQ/PPQ) and implement protocols and completion of reports.
• Prepare process flows, assembly flow diagrams, PFMEAs, perform time studies, and participate in value stream mapping activities.
• Assist in the evaluation of product performance data and internal metrics for stability and continuous improvements, utilizing Six Sigma practices where appropriate.
• Generate Risk analyses, Risk management plans, and Risk reports.
• Lead or attend customer specific daily team meetings/challenge busters (as needed).
• Review new customer documentation packages.
• Lead, execute, and support co-build activities.
• Enroll equipment into the eQMS for assigned product accounts.
• Review and generate procedures for customer processes.
• Generate equipment and fixture updates or improvement ideas.
• Update procedures as needed.
• Perform other activities as directed.

Rate: $75,000-$90,000/year (Salary commensurate with experience)

Cogmedix is an Equal Opportunity Employer. Cogmedix does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.

Required

Bachelors or better in Engineering.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.