Production Operator I

Position Overview
This role involves producing high-quality medical devices within a manufacturing cell, working under close supervision. Responsibilities include performing assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related assemblies. Tasks follow specified or standardized procedures, with work subject to continuous review.

Key Responsibilities

• Execute routine assignments with accuracy, ensuring job documentation for cell operations is current and precise.
• Communicate ideas, problems, and solutions effectively to all levels of manufacturing management in written and oral forms.
• Maintain a positive attitude when interacting with internal and external customers, including during tours.
• Adhere to safety guidelines and use appropriate safety devices during all operations.
• Participate in continuous improvement and quality initiatives to enhance production processes, targeting quality and profitability goals.
• Maintain accurate records to ensure traceability of parts, address quality issues, and support traveler and quality documentation.
• Demonstrate a basic understanding of Lean Manufacturing principles.
• Collaborate with the Manufacturing Supervisor/Manager to set and monitor individual and cell performance metrics focused on quality improvement.
• Support divisional initiatives aligned with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
• Read, comprehend, and follow written procedures; understand and execute verbal instructions.
• Utilize electronic data collection systems and computer software effectively.
• Prioritize tasks by sequencing and timing based on importance and precedence.
• Handle and maneuver small components and parts with care.
• Make critical decisions and judgments with minimal supervision.

Qualifications

• High school diploma or equivalent required.

Dress Code Requirements

• Clothing must be non-shedding, free of frayed hems, loose threads, tassels, fringes, glitter, sequins, or any dislodgeable items. Test fabric by pulling tightly; if fibers dislodge, the garment is prohibited in production areas.
• Prohibited items: Sweaters, sweater vests, loose-knit or fleece garments, turtle necks protruding above lab coats, sleeves beyond cuff length, caps, hats, scarves, or bandanas under bouffants (except custom head wraps covered by bouffants and lab coats, made of tight, clean, laundered fabric).
• All clothing must be clean, free of visible contamination (sand, mud, dirt, lint), and fit under a lab coat/gown from the waist up.
• Footwear: Shoes must be worn at all times, with stockings or socks required. Heels must not exceed 2 inches, and sandals, clogs, slippers, open-toe, open-heel, or strapped/weave shoes are prohibited. Shoe changes are allowed only in gowning rooms.
• Attire: Torsos, upper arms, and legs must be covered. No pants above the ankle, skirts above the ankle, skirts with slits, short shirts above the navel, or sleeveless tops. Ankle-length skirts require full-length stockings, leggings, or pants underneath.
• Personal Items: No nail polish, acrylic nails, artificial coatings, jewelry, or body piercings that pierce gloves or cannot be covered by gowning materials. No makeup; lip balm in stick form is allowed if applied outside production areas before hand washing. No scented products except deodorant; no lotions post-hand washing. Cover open or bleeding wounds with a bandage. Avoid offensive attire.