Production Engineer - Weekend Shift

Beta Bionics•Irvine, CA

1d•Onsite

About The Position

The Production Engineer supports both the 3rd- and 4th-shift production teams and designs, develops, and implements manufacturing processes and procedures that meet product specifications and requirements. The role ensures processes are efficient, cost-effective, safe, and compliant with applicable quality standards and regulations. As a production support resource, the engineer monitors process and equipment performance, identifies and resolves problems, implements improvements, and coordinates with internal and external stakeholders to achieve production goals and product quality. This is a full-time, onsite position with regular presence on the manufacturing floor. The regular schedule is Friday through Sunday, primarily 8:00 a.m. to 8:00 p.m. Special projects may require extended work hours, schedule adjustments, or additional coverage according to business and production needs. The role operates in a professional office environment and uses standard office equipment; personal protective equipment may be required in designated production, laboratory, or controlled areas. Travel may be required 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.
Ability to meet the position’s onsite work requirements and travel up to 5% as business needs require.

Nice To Haves

Experience in the medical device or consumer electronics industry.
Experience working in FDA-, GMP-, and ISO-regulated environments.

Responsibilities

Support company goals, policies, procedures, and Good Manufacturing Practices (GMP).
Ensure compliance with ISO 13485, FDA 21 CFR Part 820, OSHA requirements, internal policies, and 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 use equipment and materials effectively 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, clients, suppliers, and the public.
Ensure accuracy and thoroughness, monitor work quality, and consistently meet deadlines.
Practice and advocate safe work practices.
Perform other duties as assigned.