Senior Production Lead for Complex Medical Device Assembly

Cogmedix; West Boylston (MA); On-site; USD 32,000 - 37,000; Full time

Job summary

Cogmedix in West Boylston, MA is seeking an experienced production lead for electro-mechanical and opto-mechanical assembly. You will supervise production cells, coordinate priorities, and mentor staff.

The role requires 7+ years in electro-mechanical assembly, strong leadership, and compliance with ESD, MRB, and cGMP standards; you will work cross-functionally to resolve issues and drive continuous improvement.

Qualifications

• High School Diploma or equivalent required; further technical training or education preferred.
• 7+ years of electro-mechanical assembly experience; medical device manufacturing experience is a plus.
• Advanced experience with complex electro-mechanical and opto-mechanical assembly; optics handling and cleaning; epoxy dispensing tools, torque tools, crimping tools, soldering, multimeters.
• Demonstrated ability to lead cell activities, train and mentor associates, support issue resolution, and communicate effectively with internal and external customers.
• Strong working knowledge of ESD, traceability, MRB, material control, and, if medical devices are involved, cGMP, GDP, ISO 13485.

Responsibilities

• Provide advanced-level leadership and supervision support to assigned production cells and associates.
• Coordinate complex production priorities across cells and communicate status, constraints, and risks to Production Management.
• Train, mentor, and develop associates; verify required training forms and documentation are completed accurately and contemporaneously.
• Lead 6S setup for assigned cells, lead daily 6S execution, perform audits, and drive sustaining activities.
• Ensure cell status boards, visual controls, production metrics, and escalation items are accurate and current.
• Assemble highly complex electro-mechanical and opto-mechanical subassemblies, final assemblies, and customer-specific builds per specs.
• Collaborate with customers and internal teams during co-builds, production transfers, and New Product Introduction activities.
• Partner with Manufacturing Engineering, Quality, Supply Chain, Program Management, and Operations to resolve production, material, documentation, and quality issues.
• Ensure proper ESD practices, tool calibration awareness, material handling, MRB processes, traceability, and non-conforming material controls are followed.
• Identify and communicate continuous improvement, production efficiency, training, and documentation improvement opportunities to management.
• Complete and verify manufacturing documentation, Device History Records, and electronic transactions accurately and in real time.
• Follow cGMP, GDP, ISO 13485, ESD, safety, material handling, traceability, and non-conforming material requirements.
• Perform other duties as directed.

Skills

Leadership

Training & mentoring

Communication

ESD knowledge

MRB knowledge

cGMP knowledge

Teamwork

Manual dexterity

Education

High School Diploma or equivalent

Technical training or education preferred

Tools

Epoxy dispensing tools

Torque tools

Crimping tools

Soldering

Multimeters

Job description

Cogmedix in West Boylston, MA is seeking an experienced production lead for electro-mechanical and opto-mechanical assembly. You will supervise production cells, coordinate priorities, and mentor staff.

The role requires 7+ years in electro-mechanical assembly, strong leadership, and compliance with ESD, MRB, and cGMP standards; you will work cross-functionally to resolve issues and drive continuous improvement.