Lead Medical Device Instrument Assembler

Pay Range: $25.00hr - $40.00hr

Job Overview:

The Lead Assembler is responsible for the fabrication, assembly, testing, and documentation of medical device products. This role serves as a key contact between engineering and other lab assemblers in coordinating resources, schedules, and activities to ensure products are built safely, efficiently, and in compliance with quality requirements. The Lead Assembler provides technical guidance, training, and day-to-day direction to assemblers while helping achieve engineering objectives.

Responsibilities:

• Provide day-to-day leadership and guidance to assembly personnel, fostering a culture of safety, quality, accountability, and continuous improvement.
• Lead assembly team in a flexible and nimble manner as product design and assembly procedures evolve into their final state.
• Train, mentor, and support assemblers to ensure adherence to established procedures and best practices.
• Assist engineers in coordinating daily work assignments, prioritizing tasks, and resolving issues.
• Promote effective communication and collaboration across assembly and engineering teams.
• Coordinate assembly activities to ensure engineering builds are completed on a weekly basis.
• Ensure manufacturing processes are followed and updated appropriately.
• Communicate build delays, material shortages, equipment concerns, or quality issues to the appropriate engineers.
• Set up, operate, adjust, maintain, clean, and troubleshoot manufacturing and prototype equipment.
• Program equipment to perform established routines and processes.
• Coordinate the procurement and availability of materials, components, tooling, and chemicals required for development builds.
• Complete and maintain assembly build records for specified activities.
• Provide technical support and troubleshooting assistance to minimize equipment downtime and maximize productivity.
• Escalate equipment malfunctions or process issues beyond the scope of responsibility to engineering.
• Support the development and implementation of manufacturing process improvements.
• Perform visual and functional inspections to verify product quality and compliance with established specifications.
• Monitor product quality and initiate corrective actions or escalate concerns when necessary.
• Ensure compliance with all applicable quality system requirements, manufacturing procedures, and regulatory standards.
• Maintain a clean, organized, and inspection-ready work environment.
• Complete training documentation and product build documentation accurately and in a timely manner.
• Maintain clear, legible, and complete documentation in accordance with quality system requirements.
• Participate in planning meetings and provide updates on build status, risks, and resource needs.
• Perform other duties and responsibilities as assigned.
• Adhere to all company safety, environmental, and quality policies and procedures.

Reporting Structure:

The candidate reports directly to the R&D Manager while working closely with manufacturing engineering supervisors on a daily basis.

This position does not have direct supervisory authority; however, strong leadership is required to manage day-to-day activities for the assembly team.

The successful candidate provides work direction, training, and task coordination for assemblers and supports the engineering supervisor in managing daily build activities.

Education & Experience:

• High school diploma or equivalent.

Preferred Qualifications:

• Five or more years of experience in a manufacturing environment.
• Experience operating and troubleshooting production or prototype equipment.
• Experience providing team leadership, training, or work coordination.
• Experience in a regulated manufacturing environment, preferably medical devices.
• Experience supporting process improvement initiatives.

Knowledge, Skills & Abilities:

• Strong verbal and written communication skills.
• Strong leadership, interpersonal, and communication skills.
• Ability to prioritize and manage multiple tasks while remaining flexible to design and process updates on a regular basis.
• Ability to lead with some level of ambiguity with a solution-oriented mindset.
• Working knowledge of manufacturing processes and build workflows.
• Ability to operate, troubleshoot, and maintain equipment.
• Strong attention to detail and commitment to quality.
• Effective problem-solving and decision-making skills.
• Proficiency in completing manufacturing and quality documentation accurately.

Working Conditions:

• Lab environments with exposure to moving mechanical equipment, electrical systems, chemicals, solvents, and varying temperatures.
• Required use of personal protective equipment (PPE) and adherence to all safety procedures.
• May involve working with prototype equipment, manufacturing processes, and engineering development activities.

Physical Requirements(Due to nature of job, The candidate must have):

• Ability to lift 25-50 lbs occasionally.
• Ability to lift 10-20 lbs frequently.
• Ability to stand for extended periods.
• Ability to walk for extended periods.
• Ability to bend for extended periods.
• Ability to reach for extended periods.
• Ability to perform repetitive motions for extended periods.
• Ability to work with fine motor skills.
• Ability to maintain attention to detail during assembly operations.