Job Title:

Production Operator Location:

Westbrook, ME 04092

Duration:

12 months

Shift:

6am - 2:30pm

M-F Pay:

$21.00 - $23.00/hr on W2 Job Summary The Medical Device Manufacturing Operator is responsible for producing high-quality medical devices within a 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 requires strong attention to detail, the ability to work with small components, and strict adherence to quality, safety, and manufacturing procedures. Key Responsibilities Perform assembly, repair, and testing operations on medical device components and assemblies. Manufacture pacemakers, ICDs, leads, and related medical devices according to established procedures and specifications. Follow standardized work instructions, written procedures, and verbal instructions accurately. Maintain accurate and up-to-date job documentation for manufacturing cell operations. Perform routine production assignments while maintaining required quality and productivity standards. Handle and maneuver small components and parts with precision and care. Maintain accurate traveler and quality documentation to ensure complete product traceability. Identify and communicate quality issues, production problems, and potential solutions to manufacturing management. Use electronic data collection systems and applicable computer software to document production activities. Participate in continuous improvement and quality initiatives to improve production processes, quality, and profitability. Apply basic Lean Manufacturing principles within daily production activities. Follow all safety guidelines and properly utilize required safety devices and equipment. Maintain a clean, organized, and contamination-controlled production environment. Work with Manufacturing Supervisors/Managers to establish and monitor individual goals and cell performance metrics. Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other applicable regulatory requirements. Interact professionally with internal and external customers, including facility tours. Prioritize work by determining the appropriate sequence and timing of assigned jobs. Make sound decisions and judgments while working with minimal supervision. Support divisional initiatives and other manufacturing projects as assigned. Required Qualifications High school diploma or equivalent. Ability to read, comprehend, and follow written procedures and verbal instructions. Ability to handle and maneuver small components and parts. Basic computer skills and ability to use electronic data collection systems. Strong attention to detail and ability to maintain accurate documentation. Ability to prioritize work based on urgency and importance. Ability to make sound decisions and judgments with minimal supervision. Strong written and verbal communication skills. Ability to work effectively in a team-oriented manufacturing environment. Basic understanding of Lean Manufacturing and continuous improvement principles. Ability to follow strict safety, quality, and regulatory requirements. Manufacturing Environment & Dress Requirements Because this position involves medical device manufacturing, employees must follow strict production-area requirements: Wear clean, non-shedding clothing free of loose threads, frayed hems, glitter, sequins, tassels, or other materials that could become dislodged. Clothing must fit completely under the required lab coat/gown. Sweaters, fleece, loose-knit, and loose-fiber garments are not permitted. Shoes must be fully enclosed with a heel no higher than 2 inches. Open-toe, open-heel, sandal, clog, slipper, and similar footwear is prohibited. Socks or stockings are required. Torsos, upper arms, and legs must remain covered. Loose-fitting clothing is not permitted around machinery or soldering/brazing equipment. Caps, hats, scarves, or bandanas must not be worn under the bouffant unless specifically permitted and fully covered according to gowning requirements. Nail polish, acrylic nails, artificial nails, and similar nail coatings are prohibited. Jewelry or body piercings that may puncture gloves or cannot be covered by gowning materials are not permitted. Makeup and scented personal-use products are not permitted in production areas. Open or bleeding wounds must be properly covered with a bandage. All clothing must be clean and free of visible contamination such as dirt, mud, sand, or lint. AB01

Pay:

$21.00 - $23.00 per hour

Work Location:

In person