Axelon
Job Title: Operator I
Job Location: Irving, TX
Shift hours: Mon - Fri/6 am - 2:30 pm
Position Summary: This role is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, the Medical Device Assembler performs assembly, repair, and testing of pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related components. The position follows standardized procedures to ensure accuracy, compliance, and product integrity.
Key Responsibilities: Perform assembly, repair, and test operations on medical device components in accordance with documented procedures. Ensure job documentation and records are accurate, complete, and compliant with quality standards and traceability requirements. Operate within safety guidelines, utilizing appropriate protective equipment and tools at all times. Support continuous improvement and lean manufacturing initiatives to enhance efficiency, quality, and profitability. Conduct routine inspections and quality checks to ensure all products meet required standards. Communicate clearly with supervisors and team members to report issues, propose solutions, and support manufacturing goals. Participate in setting and achieving performance metrics aligned with departmental objectives. Adhere to all divisional initiatives supporting Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Skills & Qualifications:
High school diploma or equivalent required. Ability to read, comprehend, and follow written procedures as well as verbal instructions. Basic understanding of electronic data collection systems and software applications. Strong attention to detail with the ability to handle and assemble small components. Good decision-making skills with the ability to prioritize and sequence tasks effectively. Strong communication skills and a positive, professional attitude when interacting with colleagues and visitors. Work Environment & Dress Code: To ensure product integrity and safety, employees must comply with strict gowning and dress code requirements, including:
Clothing must be clean, non-shedding, and free of loose threads, fibers, or embellishments (e.g., glitter, sequins, tassels). Sweaters, fleece, or loosely knit garments are not permitted; all clothing from the waist up must fit under a lab coat/gown. Shoes must be closed-toe, closed-heel, and flat (heels not exceeding 2 inches); sandals, clogs, slippers, or woven-toe shoes are prohibited. Jewelry, body piercings, nail polish, artificial nails, and makeup are not allowed in production areas. Personal care products must be fragrance-free, except deodorant. All wounds must be properly covered, and personal protective equipment (PPE) must be worn as required. or bleeding wound with a bandage. Dont wear anything that could be offensive."
Position Summary: This role is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, the Medical Device Assembler performs assembly, repair, and testing of pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related components. The position follows standardized procedures to ensure accuracy, compliance, and product integrity.
Key Responsibilities: Perform assembly, repair, and test operations on medical device components in accordance with documented procedures. Ensure job documentation and records are accurate, complete, and compliant with quality standards and traceability requirements. Operate within safety guidelines, utilizing appropriate protective equipment and tools at all times. Support continuous improvement and lean manufacturing initiatives to enhance efficiency, quality, and profitability. Conduct routine inspections and quality checks to ensure all products meet required standards. Communicate clearly with supervisors and team members to report issues, propose solutions, and support manufacturing goals. Participate in setting and achieving performance metrics aligned with departmental objectives. Adhere to all divisional initiatives supporting Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Skills & Qualifications:
High school diploma or equivalent required. Ability to read, comprehend, and follow written procedures as well as verbal instructions. Basic understanding of electronic data collection systems and software applications. Strong attention to detail with the ability to handle and assemble small components. Good decision-making skills with the ability to prioritize and sequence tasks effectively. Strong communication skills and a positive, professional attitude when interacting with colleagues and visitors. Work Environment & Dress Code: To ensure product integrity and safety, employees must comply with strict gowning and dress code requirements, including:
Clothing must be clean, non-shedding, and free of loose threads, fibers, or embellishments (e.g., glitter, sequins, tassels). Sweaters, fleece, or loosely knit garments are not permitted; all clothing from the waist up must fit under a lab coat/gown. Shoes must be closed-toe, closed-heel, and flat (heels not exceeding 2 inches); sandals, clogs, slippers, or woven-toe shoes are prohibited. Jewelry, body piercings, nail polish, artificial nails, and makeup are not allowed in production areas. Personal care products must be fragrance-free, except deodorant. All wounds must be properly covered, and personal protective equipment (PPE) must be worn as required. or bleeding wound with a bandage. Dont wear anything that could be offensive."