Job Description

Applies skill and dexterity in the preparation of raw tissue materials for the manufacturing process, in keeping with regulatory and company guidelines and provides training, guidance, and oversight to co-workers in team's effort to meet production targets.

Key Responsibilities:

• Expertly use and/or instruct others in the use of tools - scalpel/blade, scissors, forceps, specialized tooling and equipment, to perform assigned steps in rotation within functional operations, following work order instructions and drawings, using computers to navigate drawings, and entering parts status data.
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records in JDE and other automated production systems
• Monitor, train, and may retrain operator according to training requirements. Involved in the certification and recertification process as needed.
• Inventory reconciliation at start of day and when transitioning to next work order.
• May conduct training as deemed necessary, as confirmed with supervisor. Ensure operators on team are fully trained to perform assigned tasks, including those associated with revisions.
• Escalate production and staff issues to supervisor; mediate technical issues with engineering staff and provide feedback to Quality on product defects, and also follow through to establish resolution and ensure continuous line production
• Partner with quality to align on defect determinations and Generate work orders from JDE for entire team.
• Other incidental duties (e.g. occasional photo copying or deliveries)

Education and Experience:
Secondary Education Preferred
6 years years experience related pericardial tissue processing or sewing, GMP, clean room, medical device experience; Demonstrated ability to lead teams, coach others, and transfer knowledge Required

Additional Skills:

• Ability to guide other workers/colleagues in understanding operations and quality standards
• Computer proficiency, e.g., email, JDE, and electronic documentation systems
• Good hand eye coordination, required
• Excellent communication and interpersonal relationship skills, including ability to convey training in methodology and procedures
• Strong English language skills, including reading, comprehending, speaking and writing
• Must be able to promote and work in an inter-department team environment and other departments, including exchanging work methodology feedback and other information related to improving performance of required tasks
• Successful completion of ongoing job training of assembly process steps
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control