Production Engineer - 2nd Shift at Beta Bionics in Irvine, CA

Job description

About Beta Bionics Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions – and a better life for those living with diabetes – with the world’s first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates. The only number needed to get started with the iLet Bionic Pancreas is a user’s weight – the iLet does the rest. The iLet lets users “Go Bionic” with their diabetes management. *User must be carb aware. Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact. Please contact us if you fit the profile below and if you are interested in joining the Beta Bionics team! Summary/Objective: This position supports the 2nd shift production team, whose scheduled hours are 3:45 p.m. to 2:15 a.m., Monday through Thursday. The Production Engineer designs, develops, and implements manufacturing processes and procedures that meet product specifications and requirements. The position ensures production processes are efficient, cost-effective, safe, and compliant with applicable quality standards and regulations. As a key production support resource, the engineer monitors process and equipment performance, identifies and resolves problems, implements improvements, and coordinates with engineers, technicians, operators, managers, customers, suppliers, and other stakeholders to achieve production goals and product quality. Essential Duties and Responsibilities [Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company’s HR contact] Support company goals and objectives, policies and procedures, and Good Manufacturing Practices (GMP). Ensure compliance with ISO 13485, FDA 21 CFR Part 820, OSHA requirements, internal policies, and other applicable quality and safety regulations. Make timely decisions using analysis, experience, judgment, and available data. Monitor and analyze key performance indicators, including yield, scrap, downtime, and cycle time, and implement corrective actions as needed. Develop process improvements that effectively utilize equipment and materials to maximize production. Implement continuous improvement initiatives using Lean manufacturing principles and tools. Troubleshoot and resolve technical issues involving machinery, equipment, or software using root cause analysis and corrective action techniques. Coordinate multiple project activities concurrently to meet timelines, use resources effectively, and adapt to changing priorities in a start-up environment. Collaborate with Engineering, Quality, Maintenance, Supply Chain, technicians, operators, managers, and other cross-functional partners to support production goals. Communicate with customers, suppliers, and other stakeholders as needed to support customer satisfaction and product quality. Establish and maintain professional working relationships with all levels of staff, clients, suppliers, and the public. Demonstrate accuracy and thoroughness, monitor work to ensure quality, and consistently meet deadlines. Practice and advocate safe work practices at all times. Perform other duties as assigned. Required Education and Experience Knowledge, Skills & Abilities: Ability to apply Quality System Regulation and Good Manufacturing Practice principles. Ability to use basic hand tools, including drills, soldering irons, micrometers, and calipers. Abi