Manufacturing Technician

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 **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**