Associate Heart Valve Specialist

Role Overview

This position involves precise and skilled sewing of both tissue and synthetic components integral to medical device manufacturing, adhering strictly to company and regulatory standards.

Primary Responsibilities

• Utilize specialized tools, such as needles, scissors, forceps, microscopes, magnifying lamps, and Manufacturing Execution Systems (MES), to carry out assigned sewing assembly tasks on stent valves in a rotational manner.
• Conduct verification checks on completed assembly steps to ensure alignment with technical specifications.
• Comply rigorously with prescribed work instructions and Standard Operating Procedures (SOPs), documenting traceable information in device history records including entries into systems such as JDE and MES.
• Manage line clearance procedures by thoroughly cleaning and sanitizing workstations at shift start and during transitions between work orders.
• Perform meticulous visual inspections using microscopes and sequentially review peer work.
• Execute ancillary duties including general housekeeping of the work area, sanitization with approved agents, material handling, and printing tasks.

Qualifications and Experience

• Secondary education is required; prior experience in sewing, Good Manufacturing Practice (GMP), clean room environments, or medical device production is an advantage but not mandatory.

Additional Skills and Attributes

• Proficient in handling small hand tools, exhibiting excellent hand-eye coordination and refined manual dexterity.
• Basic understanding of manufacturing processes and procedures.
• Preferable basic computer literacy.
• Effective communication skills with fluency in English - reading, writing, and speaking.
• Ability to work collaboratively within a team and follow detailed manufacturing instructions with minimal supervision.
• Successful completion of continuous training on assembly process steps.
• Exceptional attention to detail in execution.
• Compliance with all company policies, including pandemic protocols and Environmental Health & Safety guidelines, actively contributing to injury prevention, environmental protection, and pollution control within their area of influence.