Tissue Processor

Primary Duties and Responsibilities

• Production Line:

Additional information

Tissue Processing - Carry out general production activities pertaining to the manufacture of medical devices within a cleanroom area, including:

• Following established standard operating procedure and work instruction precisely
• Ensure correct labeling, storage and handling of chemicals, solution and tissues
• Operate and maintain laboratory equipment for chemical testing and tissue thickness measurement
• Mold and drape tissue over metal surfaces while sustaining attention to detail for extended periods
• Apply visual precision to clean raw tissue by removing collagen fiber and accurately trim processed tissues
• Prepare, measure, and mix chemical reagents for tissue processing
• Conduct terminal sterilization of tissue in various sizes while ensuring compliance with quality and safety standards

Assembly and Packaging - General Assembly of medical devices including

• Hand assembly and operation of tools and equipment for product finishing
• Mechanical, Laser, and other Cutting and Etching processes
• Operating both small and large automated equipment
• Packaging and labelling of final product

Production Support - Assist with manufacture support duties as required, including:

• Receipt of garments and transfer into classified storage areas
• Cleaning down and passing in of stock into the clean room
• Cleaning of reusable items for manufacture using washer disinfector and autoclave cycles. Maintaining cycle records
• Cleaning of equipment
• Coordination of waste removal

Continuous Improvement

• Attend and participate in departmental and organizational meetings as required
• Provide ideas and actively engage in continuous process improvement

2..Quality

• Assist with labelling and storage of material.
• Participate in internal and external audits as required.
• Training:
• Complete GMP training at least once annually.
• Complete all required training for assigned duties.
• Ensure all training documentation is maintained and updated.

Skills, Knowledge, Experience & Qualifications

• Requires a high school diploma / GED
• 1+ year of experience processing bovine or porcine tissue strongly desired
• Previous experience as a Medical Sewer and Tissue Processor is a plus
• Excellent eye for detail and fine motor skills a must.
• Clear handwriting and other Good Documentation Practice skills
• Sound communication and interpersonal skills.
• Ability to work in laboratory and cleanroom settings where PPE and special gowning requirements are required.
• Excellent English communication skills (written and verbal) are required, with the ability to convey information clearly and professionally.

Physical Requirements

• Ability to perform highly precise manual work comparable to micro-assembly of small biological tissue components under magnification.
• Excellent fine motor skills and hand-eye coordination required.
• Ability to stand or sit for extended periods of time, often for the majority of the work shift.
• Ability to perform repetitive hand and finger movements requiring high levels of dexterity and precision.
• Ability to lift and move materials up to 25 pounds (or another weight appropriate for your environment).
• Ability to maintain steady hand control for delicate work involving small components or biological materials.
• Ability to work under magnification, including frequent use of microscopes or magnifying equipment for extended periods.
• Ability to visually inspect small components or tissue structures with a high degree of accuracy.
• Ability to maintain sustained focus on detailed tasks in a production or laboratory environment.

Work Environment

• Work is performed in a cleanroom and/or controlled laboratory environment.
• Employees must adhere to strict gowning procedures, which may include wearing gowns, gloves, masks, hair covers, and shoe covers.
• Must be able to work comfortably in a temperature- and humidity-controlled environment.
• May require handling biological materials, including treated animal tissue, in accordance with established safety and regulatory protocols.
• Must follow cGMP, ISO, and company quality system procedures at all times.
• Ability to work in a highly regulated medical device manufacturing environment with strict documentation and process controls.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Target base salary range

$22 - $26 /hr. Final compensation will be based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.

Health and Wellness Offerings

• Medical, Dental, and Vision Offerings
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays & Vacation
• Employee Assistance Program
• Inclusive Team Environment

This is the national market pay scale.

Salary Range $22—$26 USD

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.