Manufacturing Technician

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 Manufacturing Technician is responsible for performing precision assembly, processing, and inspection of Class II & III medical devices in a highly regulated environment. This role ensures products are manufactured in accordance with approved procedures, quality standards, and regulatory requirements, contributing directly to the delivery of safe and effective medical devices.  Production & Assembly  Perform assembly, processing, and packaging of medical devices following detailed work instructions and SOPs  Execute tasks requiring precision, attention to detail, and fine motor skills  Operate manufacturing equipment and tools in accordance with established procedures  Meet production targets while maintaining strict quality standards  Quality & Compliance  Follow FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP)  Complete accurate documentation in accordance with Good Documentation Practices (GDP)  Perform in-process inspections and identify nonconformances  Escalate quality or safety concerns to leadership as appropriate  Team & Operational Support  Collaborate with team members and cross-functional partners to support production goals  Participate in training, cross-training, and continuous learning initiatives  Maintain a clean, organized, and compliant work environment  Support process improvements and lean manufacturing activities  Process Development & Optimization  Support process transfer from development through validation and commercialization for Class II & III medical devices  Support development, characterization, and optimization of balloon catheter and steerable sheath manufacturing processes including braiding, reflow, thermal bonding, adhesive bonding, and handle assembly operations  Drive manufacturing improvements focused on efficiency, reliability, and reduction of manual variability  Support root cause investigations, and continuous improvement initiatives  Apply problem-solving methodologies to resolve technical issues  Participate in risk management activities in accordance with ISO 14971 and FDA quality system requirements  Validation & Compliance  Contribute to validation activities including IQ, OQ, PQ, TMV, and IMV  Support engineering in development of protocols, reports, and technical documentation in accordance with GMP and regulatory requirements  Create and maintain work instructions and related engineering documentation  Support equipment qualification, calibration activities, and test method validation efforts  Partner with Quality and Manufacturing teams to maintain compliance with ISO 13485 and FDA Quality System Regulations  Key Competencies  Attention to detail and quality-focused mindset  Strong manual dexterity and hand-eye coordination  Ability to work both independently and as part of a team  Reliability and accountability in meeting production expectations  Willingness to learn and adapt in a fast-paced environment  Skills, Knowledge, Experience & Qualifications  Required  High school diploma or equivalent  3+ years of experience in manufacturing, assembly, or production (medical device preferred)  Strong attention to detail and ability to follow written procedures exactly  Ability to work in a regulated environment  Preferred  Experience in Class II or III medical device manufacturing  Background in precision assembly or catheter assembly, balloons or braided shafts  Familiarity with GMP, FDA, and ISO standards  Previous cleanroom experience  Physical Requirements  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 maintain sustained focus on detailed tasks in a production or laboratory environment.  Ability to wear cleanroom gowning and PPE as required  Work Environment  Work is performed in a controlled manufacturing and/or cleanroom environment  Requires strict adherence to GMP, FDA, and ISO standards  Use of specialized tools, microscopes, or precision equipment may be required  Collaborative, team-oriented environment with a focus on quality and compliance  May require shift work or schedule flexibility depending on production needs  Compensation: Target base salary range: $24 - $30 /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. Inclusive Team Environment • 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 This is the national market pay scale.Salary Range$24—$30 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.