Tissue Processor – Cleanroom Medical Device Production

Anteris Group; Maple Grove (MN); Ibrido; USD 30.000 - 36.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental, Vision

401k + Company Match

Paid Holidays & Vacation

Employee Assistance Program

Descrizione del lavoro

Anteris Technologies seeks a Tissue Processor to join our production team in Minnesota. You will perform tissue processing, assembly, and packaging for medical devices in a cleanroom, following SOPs and QA protocols.

The role is contract-to-hire with potential for full-time conversion after the initial period. The position requires a high school diploma, 1+ year tissue processing experience, and strong documentation and English communication skills.

Competenze

• 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.
• Clear handwriting and other Good Documentation Practice skills.
• Excellent English communication skills (written and verbal).

Mansioni

• Carry out tissue processing for medical devices in a cleanroom environment.
• Assemble and package medical devices including hand tools and automated equipment.
• Assist with quality, labeling, storage and audits as required.
• Participate in GMP training and maintain training records.

Conoscenze

English communication

Documentation skills

Teamwork

Formazione

High school diploma / GED

Descrizione del lavoro

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.

We are seeking Tissue Processors to join our production team. In this role, you will be involvedwithmany aspects ofmanufacturingfrom tissue processing to various assembly activities.

At Anteris® Technologies,you'llbe part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

This role is offered on acontract-to-hirebasis . Candidates who successfully meet performance goals and key milestones during the initial three-month contract period will be considered for conversion to a full-time role.

Shift: Monday - Friday, 5:00 a.m. - 1:00 p.m.

Primary Duties and Responsibilities

1. Production Line:

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,solutionand tissues
• Operate andmaintainlaboratory 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 invarious sizeswhile 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 asrequired, 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
• Attend andparticipatein departmental and organizational meetings asrequired
• Provide ideas and actively engage in continuous process improvement

2.. Quality:

• Assistwith labelling and storage of material.
• Participate in internal and external audits asrequired.

3. 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
• Previousexperience as a Medical Sewer and Tissue Processor is a plus
• 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 coordinationrequired.
• 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 movementsrequiringhigh levelsof dexterity and precision.
• Ability to lift and move materials up to 25 pounds (or another weightappropriate foryour environment).
• Ability tomaintainsteady 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 tomaintainsustained focus on detailed tasks in a production or laboratory 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 withestablished safety and regulatory protocols.
• Must follow cGMP, ISO, and company quality system proceduresat 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.

Compensation:

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.
• Collaborativeand 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

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.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. 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.

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