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%