Medical Device Assembler

Job Title : Medical Device Assembler

Job Location : Scarborough, ME

Shift Hours : AM - : PM (Monday - Friday)

JOB DESCRIPTION :

• This position is responsible for the production of high quality cardiovascular medical devices on a team within a manufacturing cell.
• This position includes detailed assembly and operation of various equipment and machinery per documented procedures.
• This may include electronic assembly, casting / coating functions, mechanical assembly and packaging.
• Cleans tools and equipment per documented procedures.
• Disposes hazardous waste material on corresponding hazardous waste areas.

RESPONSIBILITIES :

• Performs work required for the assembly of components, devices and / or the final product.
• Performs routine work in all production areas with limited supervision
• Ensures quality of product using standard operating procedures, templates, training and supervision, and good judgment
• Provides input for enhancing efficiencies and modifying / creating SOPs to ensure accuracy / quality or improve productivity
• May be subject to call back or extended hours as required
• Assembles medical devices and related components.
• Depending on work area, it may be a controlled cleanroom environment.
• May include use of microscopes, use of hand tools, razor blades, syringes, soldering, adhesive bonding, and operating various equipment.
• Performs routine assignments according to specified and / or standardized procedures.
• Work is closely and continually reviewed.
• Performs visual inspection and precision measurements on components and assemblies.
• Performs tests on units using computerized test equipment.
• Repairs and corrects devices / components using microscopes and applicable tools.
• Packages devices ensuring all parts are accurate and documentation is complete.
• Maintains accurate records to ensure travelers, shop floor paperwork and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products.
• Follows safety guidelines and utilize appropriate safety devices and equipment when performing all operations.
• Participates in continuous improvement / quality initiatives to enhance production processes to achieve quality and profitability metrics.
• Notifies supervisor or lead of the need to replenish supplies / materials and of any production difficulties that cannot be readily corrected.
• Participates with the Manufacturing Supervisor / Manager in setting and monitoring individual goals and cell performance metrics that continuously seek to improve the quality of operations.
• Cooperates in keeping a clean, sanitary work environment throughout the building.
• Performs other related duties as directed or assigned.

REQUIREMENTS :

• Must be able to read, comprehend and follow English written procedures at a th grade level.
• Must have good basic math skills at a th grade level.
• Must be able to speak, follow verbal instructions and communicate effectively in English.
• Possesses understanding of and ability to utilize electronic data collection systems and computer software packages.
• Must have good dexterity to handle and maneuver small components and parts.
• Ability to prioritize work by determining the sequencing and timing of different jobs based on precedence and importance.
• Ability to make critical decisions and judgments with minimal supervision.

BASIC QUALIFICATIONS EDUCATION :

• High school diploma or general education degree (GED) or equivalent combination of education and experience.
• years’ experience in a manufacturing environment.
• Knowledge and demonstrated understanding of GMP and how it applies to specific responsibilities and manufacturing operations.

PREFERRED QUALIFICATIONS :

• Demonstrated knowledge and / or understanding of medical device manufacturing.
• Prior Machine Operation experience in a manufacturing environment.

COMPETENCIES :

• Skill in using computer applications including spreadsheet, database, and word processing software.
30+ days ago