Sterilization Technician
3 days ago
Minneapolis
Job Description 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. The Sterilization Technician is an entry-level role providing technical support to the engineering team, with the primary focus on supporting product sterilization, final product packaging, and labeling operations. This position assists with routine operational tasks, including equipment setup and maintenance, data collection, material handling, and documentation. Working under the guidance of senior staff, the technician helps ensure efficient daily operations while gaining hands-on exposure to engineering processes, product development, and manufacturing support. Key Responsibilities • Perform assigned tasks related to the sterilization process, final product packaging, and labeling in compliance with company procedures and the Quality Management System., • Execute pre and post sterilization activities, including sterilant solution preparation, product transfer and labelling, leak testing and ERP related activities, and monitoring sterilization cycles using approved systems., • Execute finished-good product packaging and labeling and ensure products are shipped out on time., • Support routine equipment checks, cleaning, and maintenance activities, and assist engineers in conducting tests, collecting data, and preparing samples., • Operate lab and test equipment as trained; perform basic troubleshooting and identify and report any nonconformances, deviations, or equipment malfunctions in accordance with quality procedures., • Identify procedural gaps and propose redlines or updates to procedures to improve clarity, compliance, and efficiency., • Follow GDP, accurately document results and maintain records using established formats and systems., • Perform basic cleanroom support activities (e.g., handling materials, environmental monitoring) as required., • Follow gowning procedures and maintain compliance with controlled environment requirements (e.g., ISO Class 7/8 cleanroom standards)., • Participate in training, continuous improvement initiatives, and cross-functional activities as assigned., • Carry out other duties as assigned by the manager or delegate. Skills, Knowledge, Experience & Qualifications Required: • High school diploma or equivalent with 0–2 years of experience in a regulated manufacturing or engineering environment (e.g., medical device, pharma, aerospace, or similar), or an associate's degree in a technical field or trade school certification., • Basic understanding of sterilization principles (e.g., steam, ethylene oxide, or radiation) and product packaging process., • Familiarity with Good Documentation Practices (GDP) and quality systems, • Ability to follow detailed procedures and work instructions accurately, • Strong attention to detail and organizational skills, • Basic computer skills for data entry and record review (Excel, Word, Outlook), • Effective verbal and written communication skills. Preferred: • Familiarity with reading basic engineering drawings and product specifications., • Experience with equipment calibration, preventive maintenance, or testing processes., • Experience with Microsoft Office (Word, Excel, Outlook)., • Prior experience in a regulated environment (ISO 13485, FDA, or similar) or heart valve manufacturer. Physical Requirements • Ability to stand or sit for extended periods of time, often for the majority of the work shift., • 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 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. Compensation Target base salary range: $23 - $28 /hr, plus eligibility for an annual short-term incentive (STI) targeted at 5% of base salary and equity participation. Final compensation will be determined 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. This is the national market pay scale. Salary Range$23—$28 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.