Lead Mechanical Assembler, Medical Device

Our client company is committed to bettering the lives of their employees patients, and customers and is a leading distributor of medical devices and solutions. They support a wide range of facilities including hospitals, aesthetics, EMS, pain management, and more. The company produces a wide variety of products that exemplify their mission to improve the patient experience, lower costs, save valuable time, and reduce risk. Beyond their corporate missions, they endeavor to help their team build relationships, develop professionally, and give back to the community. Before forming their American unit, the company was a trusted provider of respiratory and anesthesia solutions for over 25 years in Canada.

The company is seeking a hands-on Lead Mechanical Assembler to support the assembly, testing, inventory coordination, quality control, and production of mechanical devices in a small manufacturing environment. This role is primarily focused on mechanical assembly, with additional responsibilities in production planning, inventory management, basic electrical work, quality documentation, regulatory adherence, and day-to-day coordination other assemblers.

The ideal candidate will be mechanically inclined, detail-oriented, organized, and comfortable working in a practical shop or production setting. This is a working lead position, not a desk-only management role. Experience working in an ISO 13485 or similarly regulated manufacturing environment is strongly preferred.

Key Responsibilities

Mechanical Assembly

• Assemble mechanical devices, subassemblies, and components according to drawings, work instructions, bills of material, and production requirements.
• Use hand tools, power tools, fixtures, and basic shop equipment safely and accurately.
• Fit, align, fasten, adjust, and inspect mechanical components during assembly.
• Identify fitment issues, missing parts, defects, nonconformances, or process concerns and communicate them clearly.
• Perform basic troubleshooting on assembled products.
• Maintain a clean, organized, and safe work area.

Production Planning and Coordination

• Assist with daily and weekly production planning.
• Help prioritize builds based on customer orders, inventory, material availability, quality requirements, and production deadlines.
• Coordinate parts, materials, documentation, and work instructions before assembly begins.
• Track build progress and communicate delays, shortages, quality issues, or documentation concerns.
• Support continuous improvement of assembly procedures, layout, tools, workflow, and quality processes.

Inventory Management

• Monitor inventory levels for components, hardware, consumables, tools, and assembly materials.
• Pull, stage, and organize parts required for upcoming builds.
• Identify shortages, damaged parts, incorrect items, expired materials, or inventory discrepancies.
• Assist with receiving, counting, labeling, and putting away incoming materials.
• Maintain organized inventory storage areas, bins, shelves, and production staging locations.
• Help perform cycle counts and basic inventory reconciliations.
• Communicate low-stock items or replenishment needs to purchasing or management.
• Support accurate tracking of parts used in production and materials returned to stock.
• Follow proper material handling, lot control, traceability, and segregation procedures where applicable.

Quality and Regulatory Compliance

• Perform in-process and final quality checks according to work instructions, inspection criteria, and quality procedures.
• Ensure assemblies are built in accordance with approved drawings, specifications, procedures, and quality standards.
• Complete production records, inspection forms, travelers, checklists, and other required documentation accurately and on time.
• Follow ISO 13485 quality system requirements, company SOPs, good documentation practices, and applicable regulatory procedures.
• Identify, document, and escalate nonconforming materials, products, or processes.
• Support corrective and preventive action activities by helping identify root causes, process issues, or recurring assembly problems.
• Maintain product traceability, material identification, and proper documentation throughout the build process.
• Support audits, process reviews, and quality improvement activities as needed.
• Ensure tools, equipment, fixtures, and measuring devices are used properly and remain in suitable condition for production use; including calibrations.

Team Lead Responsibilities

• Provide daily direction and support to other assemblers.
• Help train the assembler on build procedures, inventory handling, quality expectations, documentation practices, ISO 13485 requirements, and safe work practices.
• Review completed work for accuracy, fit, finish, completeness, and documentation accuracy.
• Escalate personnel, production, inventory, regulatory, documentation, or quality issues to management as needed.

Electrical Assembly and Testing

• Perform light electrical assembly such as wiring, connecting terminals, routing cables, installing switches, sensors, or electrical components.
• Follow basic wiring diagrams or electrical instructions.
• Assist with basic electrical checks and functional testing.
• Identify and report electrical assembly issues, failed tests, or nonconforming results.

Qualifications

• Prior experience in mechanical assembly, equipment assembly, medical device manufacturing, regulated manufacturing, or a related hands-on technical role.
• Ability to read and follow mechanical drawings, work instructions, diagrams, bills of material, inspection criteria, and production travelers.
• Comfortable using common hand tools, power tools, measuring tools, fixtures, and shop equipment.
• Basic electrical assembly or wiring experience preferred.
• Familiarity with quality documentation, inspection records, nonconformance reporting, or production travelers preferred.
• Experience working under ISO 13485, ISO 9001, FDA-regulated, medical device, aerospace, or similarly controlled manufacturing standards preferred.
• Strong attention to detail and commitment to quality.
• Ability to organize work, prioritize tasks, and communicate clearly.
• Prior experience leading, training, or coordinating another employee is helpful but not required.
• Must be dependable, safety-conscious, and comfortable working in a small-team manufacturing environment.

Preferred Skills

• Familiarity with production scheduling, inventory shortages, work orders, bills of material, lot tracking, traceability, or build documentation.
• Experience using ERP, inventory, quality management, or work order systems is a plus.
• Understanding of good documentation practices and controlled manufacturing procedures.
• Ability to troubleshoot mechanical fit, alignment, inventory, quality, or assembly problems.
• Experience documenting process improvements, updating work instructions, or supporting quality investigations.