Production Engineer - Weekend Shift

Beta Bionics, Inc.; Irvine (CA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Comprehensive medical and dental

FSA/HSA Plan Options with company con.

401(k) with employer match

Generous vacation and holidays

Job summary

Beta Bionics, Inc. in Irvine, CA is seeking a Production Engineer to design, develop, and implement manufacturing processes for the 3rd and 4th shifts.

The role focuses on efficient, cost-effective and compliant production supporting the iLet Bionic Pancreas. You will monitor process performance, troubleshoot issues, and coordinate with Engineering, Quality, Maintenance, and Supply Chain to achieve production goals and product quality.

Qualifications

• Apply Quality System Regulation and GMP principles.
• Use basic hand tools incl. drills, micrometers, calipers.
• Read mechanical drawings and electrical schematics.
• Operate electrical/mechanical equipment and interpret results.
• Proficient in Microsoft Office and digital tools.
• Work effectively with minimal supervision in cross-functional teams.
• Communicate clearly with stakeholders and maintain attention to detail.

Responsibilities

• Support GMP and company policies.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, OSHA and quality regs.
• Make timely decisions using data and experience.
• Monitor KPIs like yield, scrap, downtime, cycle time; implement corrective actions.
• Develop process improvements to maximize production.
• Lead Lean initiatives and continuous improvement.
• Troubleshoot equipment issues using root cause analysis.
• Coordinate multiple projects to meet timelines in a startup.

Skills

GMP compliance

Quality regulations

Documentation skills

Process analysis

Root cause analysis

Cross-functional teamwork

Education

Bachelor’s in Mechanical/Industrial/Biomedical Engineering

Tools

Micrometers

Calipers

Soldering irons

Drills

Microsoft Office

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.

Summary/Objective

This position supports both 3rd shift and 4th shift production teams. Work schedule: Friday through Sunday, primarily 8:00 a.m. to 8:00 p.m.

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.
• 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.

Minimum Certifications/Educational Level:

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or an equivalent combination of education and applicable work experience.

Minimum Experience:

• 2-5 years of relevant experience in a medical device manufacturing environment.
• Experience in the medical device or consumer electronics industry.
• Experience working in FDA, GMP, and ISO-regulated environments.

Work Schedule

• Full-time, onsite position with regular presence on the manufacturing floor.
• Special projects may require extended work hours, schedule adjustments, or additional coverage based on business and production needs.
  

Work Environment and Personal Protective Equipment

• This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, and scanners. Personal Protective Equipment may be required when working in designated production, laboratory, or controlled areas.

Physical Demands

• While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers.
• This position requires travel up to 5% depending upon business needs.

Salary Range

$85,000 - $115,000

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule

Equal Employment Opportunity Statement

It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.