Senior Production Operator - Crimper

Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

The Sr Production Operator role is broad, with the individual involved with many aspects of manufacturing, from Tissue Processing to various Assembly and Packaging activities.

At Anteris Technologies, you'll be 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.

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:

• Processing of incoming raw tissue.
• Reagent treatment of processed tissue
• Media changes of processed tissue
• Draping and crosslinking of tissue
• Cutting tissue to size
• Measuring cut tissue thickness
• Cleaning of cut tissue (removal of collagen fibers)
• Terminal sterilization of tissue sizes

Assembly and Packaging:

• General Assembly of medical devices including gluing, welding, soldering, and hand assembly
• 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 and completing stock transfer forms.
• Cleaning of reusable items for manufacture using washer disinfector and autoclave cycles. Maintaining cycle records.
• Cleaning of equipment.
• Coordination of waste removal.
• Chemical and Solutions Mixing

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.

3. Training:

• Complete GMP training at least once annually.
• Complete all required training for assigned duties.
• Ensure all training documentation is maintained and updated.

4. Other responsibilities as assigned.

Required Skills and Knowledge

• High School diploma or equivalent
• 5+ years of overall experience in Medical Device (ISO 13485, FDA QSR) manufacturing environment.
• 2+ years' work experience directly applicable to the Primary Duties and Responsibilities listed above.
• Previous experience with laser cutting of bovine or porcine tissue
• Excellent eye for detail and fine motor skills.
• Knowledge of GMP and cleanroom practices
• Clear handwriting and other Good Documentation Practice skills
• Able to read and write in English
• Possess basic math skills
• Able to read blueprints
• Previous experience using a microscope
• Sound communication and interpersonal skills.
• Ability to work in laboratory and cleanroom settings where PPE and special gowning requirements are required.
• Previous experience with measurement systems and fluid dispensing is a plus.

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 Plans
• 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

Note: We may require proof of COVID-19 vaccination to comply with the 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.