HiringCafe
Posted 6d ago

Production Operator

@ Anteris Technologies
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Maple Grove, Minnesota, United States
$20-$24/hrOnsiteContract, Full Time
Responsibilities:Operate line, Inspect quality, Package products
Requirements Summary:High school diploma or GED; 0-3 years in medical device manufacturing; strong attention to detail; GMP/cleanroom knowledge; good documentation; PPE compliance.
Technical Tools Mentioned:GMP, Autoclave, Cleanroom practices, Documentation, Crimping
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Job Description

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 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:

 Assembly and Packaging: 

  • General Assembly of medical devices including hand assembly using laser-cut components and crimper. 
  • Conduct visual inspection of materials and finished products to ensure quality standards are met. 
  • Operate and support autoclave processes using sterile tools and materials. 
  • Packaging and labeling of finished products accurately according to work instructions. 

 

Production Support: 

  • Support daily manufacturing activities to meet quality and production goals.
  • Maintain accurate cycle records and complete required documentation.
  • Clean equipment and support proper waste removal.
  • Mix chemicals and solutions per approved instructions.
  • Clean, prepare, and transfer materials into the cleanroom following stock transfer procedures.

 

Continuous Improvement: 

  • Learn and support CI discussion and events. 



2. Quality:

  • Maintain cleanliness and organizational standards within manufacturing and laboratory environments and tools. 
  • Participate in internal and external audits as required. 



3. Training:

  • Complete GMP training at least once annually. 
  • Complete all required training for assigned duties. 

 

Required Skills and Knowledge:  

  • High School diploma, GED, or equivalent experiences. 
  • 0-3 years of overall experience in Medical Device (ISO 13485, FDA QSR) manufacturing environment. 
  • 0-2 years’ work experience directly applicable to Primary Duties and Responsibilities listed above. 
  • Excellent eye for detail and fine motor skills. 
  • Knowledge of GMP and cleanroom practices 
  • 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. 

 

Physical Requirements: 

  • 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 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. 

 

Compensation:

Target base salary range: $20 - $24 /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.
    • The chance to be part of a growing company that values its employees.

     



    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.