Medical Device Assembler
St. Paul, MN
Job Summary
This position is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, the employee may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Performs routine assignments according to specified and/or standardized procedures. Work is closely and continually reviewed.
Key Responsibilities
Ensure relevant job documentation for cell operations and functions is accurate and up to date.
Clearly communicate ideas, problems, and solutions to all levels of manufacturing management in both written and oral form.
Maintain a positive attitude when interacting with internal and external customers, such as during facility tours.
Follow all safety guidelines and utilize appropriate safety devices when performing 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 correct, all parts are traceable, and quality issues can be addressed.
Demonstrate a basic understanding of Lean Manufacturing.
Work with the Manufacturing Supervisor/Manager to set and monitor individual goals and cell performance metrics.
Support all divisional initiatives as identified by management, including compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Required Skills and Abilities
Ability to read, comprehend, and follow written procedures and verbal instructions.
Understanding of and ability to utilize electronic data collection systems and computer software packages.
Ability to prioritize work, determine sequencing and timing of tasks based on importance.
Ability to handle and maneuver small components and parts.
Ability to make critical decisions and judgments with minimal supervision.
Education: High school degree or equivalent preferred.
Dress Code Requirements (for Interviews and On-the-Job)
General:
Clothing must be non-shedding and free of frayed hems or loose threads.
No tassels, fringes, glitter, sequins (sewn or glued), or any other items that could become dislodged.
To verify if fabric is acceptable: pull at it tightly - if fibers dislodge, the garment may not be worn in the production area.
Not Allowed:
Sweaters, sweater vests, loose-fiber garments, loose knit, or fleece.
Clothing with visible contamination (sand, mud, dirt, lint, etc.).
Turtlenecks or high-necked clothing that stick out above the lab coat/gown.
Sleeves that extend beyond the cuff of the lab coat/gown.
Caps, hats, scarves, or bandanas under the bouffant (except approved head wraps).
Head Wraps / Scarves (for customs):
Must be covered with a bouffant.
Tail ends must be fully covered by the lab coat/gown.
Must be tightly woven, clean, and laundered.
Clothing Fit:
Footwear:
Shoes must be worn at all times in production areas.
Stockings or socks are required.
Heels must not be pointed or higher than 2 inches.
Not allowed: sandals, clogs, slippers, open-toe/open-heel shoes, or shoes with straps/weaves where toes can be seen.
Changing shoes in the production area (other than a gowning room) is not allowed.
Coverage:
Torsos, upper arms, and legs must be covered.
Not allowed: pants above the ankle, skirts above the ankle, skirts with slits, short shirts (above the navel), sleeveless tops.
Skirts at ankle length are allowed only with full-length stockings, leggings, or pants underneath.
Personal Appearance:
No nail polish, acrylic/artificial nails, or similar nail coatings.
No jewelry or body piercings that could pierce gloves or cannot be covered by gowning materials.
No makeup (lip balm in stick form is acceptable when applied outside production areas and before hand washing).
No scented products except deodorant.
Lotions shall not be applied after hand washing.
Cover any open or bleeding wounds with a bandage.
Do not wear anything that could be considered offensive.
|