Medical Device Assembler, Operations - Shift 2

Position Summary
The Assembler I position will inspect, weigh, package, and sort out defective medical devices as required.

Essential Duties & Responsibilities
• Keep work area clean.
• Must have excellent dexterity to manually assemble small parts using hand tools, fixtures, and/or equipment and sort product for defects as required.
• Visual inspection of product to ensure good quality using various types of magnification.
• Complete production records and work order documentation as needed.
• Weigh count, package, and label finished product.

Knowledge, Skills & Qualifications
• Able to comprehend and follow procedures as written.
• Good hand/eye coordination.
• Ability to take constructive feedback.
• Ability to work on assigned line or process at the production rate without requiring assistance from others.
• Acceptance of change and flexible to changing work environments. Willingness to learn new concepts / processes.
• Assemble parts from subcomponents (Off-Line & On-Line).
• Demonstrated ability to identify & communicate non-conformities and/or quality problems.
• Effective listening skills & communication skills.
• Supports overtime activities as required.
• Follows all safety policies per required job tasks, including utilization of designated PPE.
• Follows attendance policy and is at their designated workstation at the required time.
• Ability to take direction from supervisor, coordinator, or line/cell leader and complete assigned tasks, with a positive attitude.
• Contributes effectively as part of a team.


Assemble various components. •Work with other team members to perform basic assembly of products including preparation of parts, actual assembly, testing, recording of test results and packaging of the product to customer and government specifications. •Utilize documentation such as Bills of Material, product flow charts, work orders, check sheets, visual aids, production reports and assembly drawings to assemble product and record results. •May perform soldering, fabricating, crimping, mechanical assembly, taping, cable spooling, sealing, capping, clamping, bonding, and coiling. •Basic computer skills to review documents and to load and operate auto-baggers. •Inspects work throughout the assembly process and communicate any quality or operational issues to appropriate leader. •Assist in correcting procedures to ensure consistency of quality and efficiency. •Maintain neat, orderly and clean work area to ensure efficiency and no safety hazards. Participate in safety programs, meetings, and trainings as required. Bring safety concerns to the attention of management. Understand the hazards associated with energy sources in the workplace. •Meet all quality, quantity and good manufacturing practices to satisfy customer and Regulatory Affairs requirements. Read and/or understand operating procedures for specific products where training has been completed. •Ensure environmental conservations by shutting off equipment and lights not in use and ensuring proper recycling practices. •Ensure first pieces at the beginning of each work order. Requisition of components. Collect and weigh returns at the end of an order. Implement line clearance to start a new order. Record documentation to labor sheets, check sheets, visual aids, production sheets, and work orders. Perform cleaning as specified. Audit work orders daily. •Use proper equipment to transport finished goods to appropriate location. •This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental regulations and statutes). •This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site). •Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement. Impact and Scope: •Inattention to work area hazards could lead to unsafe conditions. Incorrect assembly of product can lead to customer complaints and lose of future sales. •Inability to follow good manufacturing practices could cause FDA concerns. •Improper documentation can lead to late orders. Key Internal and External Relationships: •Must be able to get along with all levels of employees. •Must be able to maintain professional composure.

Quals--
Education and Experience
• High School Diploma or GED desirable.
• Previous experience desirable.

Minimum Qualifications
• Must be 18 years of age.
• Must pass pre-employment drug screen and background check

Travel Requirements
• Position does not require travel.

Physical Requirements and Work Environment
• Work is performed in a clean room environment.
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating.
• Must be able to occasionally move and lift objects of up to 25 lbs.

•Three months or more manufacturing/production experience preferred. •Must be a highly motivated self-starter with people skills. •Interpersonal, verbal, and written communication skills are required. •Must be familiar with and comfortable using computers. •Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing processes preferred. •Education requirements can be obtained through an educational institution or gained through equivalent work experience. Abilities: •Must be able to read, write, and communicate effectively. •Must be able to perform basic arithmetic (multiplication, addition, subtraction, division) with the use of a calculator or computer. •Ability to distinguish colors. •Must have good hand/eye coordination. •Detail oriented. Planning and Decision Making: •Ability to make sound decisions when safety concerns arise. •Read work orders of like operation to determine assembly order sequence. •Appropriate timing to involve support leaders and/or departments. (Supervisor, Group Lead, Process tech, Maintenance, and Tooling). •Initial detection of nonconforming components. •Direct supervision and instruction will be provided department and/or site leadership