3rd Shift Molding & Assembly Leadfitchburg, MA 01420

3rd Shift Molding & Assembly Lead

The 3rd Shift Molding & Assembly Lead supports daily operations within Micron's Injection Molding and Contract Manufacturing Assembly departments by coordinating personnel, ensuring product quality, maintaining compliance with customer and regulatory requirements, and meeting production schedules. This position serves as the primary shift resource for operators and assemblers, providing leadership, hands-on support, and training to ensure safe, efficient, and compliant manufacturing operations.

The ideal candidate will have experience leading teams in a medical device or regulated contract manufacturing environment, supporting high-volume and high-complexity assembly operations, and training employees on manufacturing processes, quality standards, and documentation requirements.

Schedule: Monday-Friday, 11:00 PM - 7:00 AM

Key Responsibilities

Perform all duties of a Level 1 and Level 2 Molding Operator as needed.

Coordinate and assign operators and assemblers to machines, assembly cells, and workstations based on production priorities.

Support daily manufacturing and contract assembly operations to achieve safety, quality, delivery, and productivity goals.

Monitor production activities to ensure compliance with work instructions, quality standards, and customer requirements.

Serve as the primary floor resource for operators and assemblers during the shift.

Assist supervisors in managing workflow, staffing priorities, and production issues.

Support both injection molding and contract assembly activities, including medical device assembly operations.

Monitor and support complex assembly operations to ensure adherence to customer specifications and quality requirements.

Conduct visual inspections and verify operators complete required in-process inspections, testing, and documentation.

Ensure accurate completion of production records, shop orders, travelers, and cGDP documentation.

Verify product labeling, traceability, and inventory transactions are completed accurately.

Support quality investigations and assist with identifying and resolving production and assembly-related issues.

Ensure compliance with ISO 13485, Good Documentation Practices (GDP/cGDP), and customer quality requirements.

Lead onboarding and training activities for new operators and assemblers.

Train employees on work instructions, assembly procedures, quality requirements, documentation standards, and safe work practices.

Ensure employees are trained and retrained on process changes, product revisions, and updated work instructions.

Evaluate employee performance during training and provide coaching to improve performance and quality.

Act as a mentor and subject matter expert for molding and assembly personnel.

Assist in developing training materials, training records, and competency assessments.

Monitor machine performance and escalate equipment, process, and quality concerns appropriately.

Assist with troubleshooting molding, assembly, and production issues to minimize downtime.

Identify opportunities to improve safety, quality, productivity, efficiency, and housekeeping.

Support Lean Manufacturing and continuous improvement initiatives.

Participate in root cause investigations and implementation of corrective actions.

Promote a safe work environment and ensure proper use of PPE.

Maintain a clean and organized production area that supports efficient operations and audit readiness.

Follow and promote company quality policies and ISO 13485 requirements.

Support internal, customer, and regulatory audits as required.

Qualifications

Education

High School Diploma or GED required.

Associate's Degree in Manufacturing, Engineering Technology, or a related field preferred.

Knowledge, Skills & Abilities

Strong understanding of manufacturing operations and employee leadership.

Ability to train, coach, mentor, and develop manufacturing personnel.

Experience working with complex assembly operations and customer-specific manufacturing requirements.

Ability to read and interpret work instructions, assembly drawings, procedures, and quality documentation.

Knowledge of Good Documentation Practices (GDP/cGDP) and regulated manufacturing environments.

Experience using measuring equipment, testing devices, and quality inspection tools.

Strong organizational skills with the ability to coordinate multiple production activities.

Experience using ERP systems and electronic manufacturing documentation.

Knowledge of ISO 13485 quality systems preferred.

Strong communication, leadership, and interpersonal skills.

High attention to detail and commitment to product quality.

Experience

3+ years of experience in manufacturing, assembly, or injection molding operations.

Experience in contract manufacturing and/or medical device manufacturing environments.

Experience supporting high-volume or complex assembly operations.

Demonstrated experience training, coaching, and developing manufacturing employees.

Experience working within regulated quality systems and documentation requirements.

Prior Lead, Team Lead, Trainer, or Supervisor experience.

Experience supporting ISO 13485-regulated manufacturing operations.

Experience with medical device assembly, inspection, and packaging processes.

Experience using ERP systems such as IQMS/DELMIAWorks.

Lean Manufacturing and continuous improvement experience.

Must be able to work Monday-Friday, 11:00 PM - 7:00 AM.

Applicants must be legally authorized to work in the United States. Micron Solutions is unable to provide employment visa sponsorship now or in the future for this position and does not offer relocation assistance.

Candidates with experience in medical device assembly, contract manufacturing, workforce training, employee development, and ISO 13485-regulated environments will receive priority consideration. This role requires a hands-on leader who can effectively train employees, support complex assembly operations, and drive quality and productivity on third shift.

PM21