Team Lead, Assembler

Position Summary:

The Team Lead is responsible for assembling medical devices in compliance with applicable FDA, state, OSHA, and ISO regulations and standards. This effort includes, but is not limited to, being a team player with the ability to function well in a challenging and fast paced environment. This individual works with the entire department and the Production Supervisor to ensure all employees have the training and knowledge to assemble the products up to company standards.

Essential Functions:

• Assembles subassemblies and finished products per standard operating procedures, practices, and work instructions

• Sets up and operates production equipment in accordance with current good manufacturing practices and standard operating procedures

• Interprets blueprints and utilizes skills to ensure that assemblies are made to specifications

• Tests products and/or subassemblies for functionality or quality. This may include performing test protocols for product qualifications, and troubleshooting problems with equipment, devices, or products

• Generates assembly records for system Device History Records (DHR)

• Maintains a neat and organized work area (5S methodology)

• Separates scrap or waste materials for recycling, reuse, or environmentally sound disposal

• Assists in material cycle counting activities

• Assists in the training of new employees and of new assembly projects

• Assists management in ensuring the flow of production is continuous and even

• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies

• Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role

• Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:

• High School Diploma or its equivalent with at least one year of experience in the field or in a related area

• Ability to use a variety of tools and equipment (torque wrenches, hand tools, power supplies, meters, fixtures, and tooling)

• Familiarity with GMP environment; reading & checking Bills of Materials, schematics, and machine/assembly drawings

• Ability to work under minimum supervision with a high degree of organizational and technical competence

• Ability to function well under pressure and expend effort to meet schedules and deadlines

• Experience working for a medical device manufacturer preferred

• Excellent verbal and written communication skills

• Attention to detail

• Self-starter

• Advanced critical thinking and problems-solving skills

Physical Demands:

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl.

• Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

• Required to possess specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.