Medical Device Assembly Operator I

Job TitleResponsible for producing high-quality medical devices within a controlled manufacturing cell. Working under close supervision, this position performs a combination of assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. The role follows standardized procedures while maintaining strict quality, safety, documentation, and regulatory standards.Required Education: • High School Diploma or equivalentRequired Experience • Ability to read, comprehend, and follow written procedures and verbal instructions • Ability to perform detailed assembly, repair, and testing of small medical device components • Ability to handle and maneuver small parts and components with precision • Ability to prioritize work and determine sequencing based on urgency and importance • Ability to make sound decisions and judgments with minimal supervision • Basic understanding of Lean Manufacturing, Quality Management Systems (QMS), and Environmental Management Systems (EMS) • Ability to use electronic data collection systems and standard computer software • Strong written and verbal communication skills • Ability to follow all safety, quality, manufacturing, and regulatory requirements • Must maintain accurate documentation and ensure product and component traceability • Must comply with strict production-area gowning, clothing, footwear, hygiene, and personal-item requirementsProduction Area / Gowning Requirements • Clothing must be clean, non-shedding, and free of loose threads, frayed edges, glitter, sequins, tassels, fleece, or loose-knit materials • Clothing must fit completely under the required lab coat/gown; loose-fitting clothing is not permitted around machinery or soldering/brazing equipment • Closed-toe and closed-heel shoes are required; heels may not exceed 2 inches. Sandals, clogs, slippers, and open-toe/open-heel footwear are prohibited • Socks or stockings are required, and legs, torso, and upper arms must be appropriately covered • Nail polish, artificial/acrylic nails, makeup, and jewelry or piercings that cannot be safely covered are not permitted in the production area • Hats, scarves, and head coverings must comply with gowning requirements and be fully covered where applicable • Personal products with fragrances are not permitted, except deodorant; lotions must not be applied after hand washing • Any open or bleeding wound must be properly covered with a bandage before entering the production area • All employees and visitors must comply with the facility's gowning, hygiene, contamination-control, and safety proceduresOverviewResponsibilities • Perform routine assembly, repair, and testing of medical devices and related components according to established procedures • Ensure manufacturing documentation, work instructions, and cell-operation records are accurate and current • Maintain accurate travelers and quality documentation to ensure complete part and product traceability • Identify and communicate manufacturing problems, quality concerns, and potential solutions to supervisors and manufacturing management • Follow all established safety procedures and properly use required safety equipment and devices • Participate in continuous improvement and quality initiatives designed to improve production efficiency, quality, and profitability • Apply basic Lean Manufacturing principles to daily manufacturing activities and process improvements • Work with Manufacturing Supervisors/Managers to establish and monitor individual goals and cell performance metrics • Support quality, environmental, regulatory, and other divisional initiatives in accordance with QMS and EMS requirements • Maintain a professional and positive attitude when interacting with employees, management, internal customers, and external visitors/tours • Follow all applicable procedures related to product quality, contamination control, safety, and regulatory compliance • Exercise appropriate judgment when handling production issues and escalate concerns when necessary**Only those lawfully authorized to work in the designated country associated with the position will be considered.****Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.** Rose International