Production Engineer - 2nd Shift

Beta Bionics•Irvine, CA

1d•Onsite

About The Position

The Production Engineer supports Beta Bionics’ second-shift production team and designs, develops, and implements manufacturing processes and procedures that meet product specifications and requirements. The role helps ensure production is 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 internal and external stakeholders to meet production goals and maintain product quality. The scheduled shift is 3:45 p.m. to 2:15 a.m., Monday through Thursday. This is a full-time, onsite position with regular presence on the manufacturing floor. Special projects may require extended hours, schedule adjustments, or additional coverage based on business and production needs. The position operates in a professional office environment and may require personal protective equipment in designated production, laboratory, or controlled areas. Travel may be up to 5%, depending on business needs.

Requirements

Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or an equivalent combination of education and applicable work experience.
2–5 years of relevant experience in a medical device manufacturing environment.
Ability to apply Quality System Regulation and Good Manufacturing Practice principles.
Ability to use basic hand tools, including drills, soldering irons, micrometers, and calipers.
Ability to operate electrical and mechanical equipment and interpret test or process results.
Ability to read and interpret mechanical drawings and electrical schematics.
Proficiency with Microsoft Office and online applications.
Ability to work effectively with minimal supervision and within a cross-functional team environment.
Excellent interpersonal, verbal, and written communication skills, with meticulous attention to detail and deadlines.
Experience in the medical device or consumer electronics industry.
Experience working in FDA-, GMP-, and ISO-regulated environments.

Responsibilities

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 performance indicators, including yield, scrap, downtime, and cycle time, and implement corrective actions as needed.
Develop process improvements that effectively use 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 concurrent project activities 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 staff at all levels, 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.