Operator I

Working under close supervision, the operator performs a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Clothing Requirements (Upper Body & Outerwear): All clothing must be non-shedding and free of frayed hems, loose threads, tassels, fringes, glitter, or sequins (sewn or glued).

JOB TITLE: Manufacturing Assembly & Test Operator (Medical Devices)
POSITION TYPE: 5 Month Contract with possible extension.
LOCATION: Westford, MA
POSITION SUMMARY
This position is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, the operator performs a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. KEY RESPONSIBILITIES

• Perform routine assembly, repair, and testing tasks according to specified and standardized procedures.
• Ensure that all relevant job documentation for cell operations is accurate and up to date.
• Clearly communicate ideas, problems, and solutions to all levels of manufacturing management, both verbally and in writing.
• Maintain a positive and professional attitude when interacting with internal teams and external visitors (e.g., facility tours).
• Follow all safety guidelines and utilize appropriate safety devices during all operations.
• Participate in continuous improvement and quality initiatives to enhance production processes and achieve quality and profitability metrics.
• Maintain accurate records to ensure traveler and quality documents are complete, parts are traceable, and quality issues can be promptly addressed.
• Demonstrate a basic understanding of Lean Manufacturing principles.
• Collaborate with the Manufacturing Supervisor/Manager to set and monitor individual goals and cell performance metrics that continuously seek to improve operational quality.
• Support all divisional initiatives as identified by management, including compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

REQUIRED QUALIFICATIONS

• Education: High school diploma or equivalent required.
• Technical Skills:
  • Ability to read, comprehend, and follow written procedures and verbal instructions.
  • Proficiency with electronic data collection systems and computer software packages.
• Core Competencies:
  • Strong prioritization skills with the ability to determine sequencing and timing of tasks based on importance.
  • Excellent manual dexterity to handle and maneuver small components and parts.
  • Ability to make critical decisions and judgments with minimal supervision.

MANDATORY DRESS CODE & GROOMING STANDARDS
All candidates must adhere to the following requirements during the interview (tour) and while on the job. These standards are critical for maintaining a cleanroom-safe production environment.
Clothing Requirements (Upper Body & Outerwear):

• All clothing must be non-shedding and free of frayed hems, loose threads, tassels, fringes, glitter, or sequins (sewn or glued).
• Prohibited Fabrics: Sweaters, sweater vests, loose-fiber garments, loose knits, and fleece.
• Verification Test: Pull fabric tightly with fingers; if fibers dislodge, the garment is not permitted.
• All clothing from the waist up must fit completely under the lab coat/gown. Turtle necks and high-necked clothing must not protrude above the gown neckline. Sleeves must not extend beyond the cuff.

Headwear & Accessories:

• Caps, hats, scarves, or bandanas are not permitted under the bouffant hairnet.
• Religious head wraps/scarves are permitted only if:
  • Covered entirely by the bouffant.
  • The tail end is fully covered by the lab coat/gown.
  • Made of tightly woven, clean, laundered fabric.

Footwear:

• Shoes must be worn at all times. Stockings or socks are required.
• Permitted: Flat, closed-toe, closed-heel shoes with a heel height of 2 inches or less (non-pointed).
• Prohibited: Sandals, clogs, slippers, open-toe, open-heel, or woven/strapped shoes where toes are visible.
• Note: Changing shoes in the production area (outside of the gowning room) is not allowed.

Lower Body:

• Torsos, upper arms, and legs must be fully covered.
• Prohibited: Pants above the ankle, skirts above the ankle, skirts with slits, short shirts (above the navel), and sleeveless tops.
• Permitted: Ankle-length skirts are allowed but must be worn with full-length stockings, leggings, or pants underneath.

Personal Grooming & Prohibited Items:

• Nails: Nail polish, acrylics, artificial nails, or similar coatings are prohibited.
• Jewelry/Piercings: Body piercings or jewelry that could puncture gloves or cannot be fully covered by gowning materials are not allowed.
• Makeup: Not permitted.
• Lip Balm: Stick form only; must be applied outside production areas and prior to hand washing.
• Fragrances: Scented personal products (except deodorant) are prohibited.
• Lotions: Not permitted after hand washing.
• Wounds: Any open or bleeding wounds must be covered with a bandage.
• Appearance: Clothing must be clean, free of visible contamination (sand, mud, dirt, lint), and free of offensive graphics or language.
• Loose Clothing: Loose-fitting garments are prohibited near machinery or soldering/brazing torches.