Production Supervisor – Weekend Night Shift (4th Shift)

Beta Bionics, Inc.; Irvine (CA); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

Medical and dental coverage

HSA/FSA options with company HSA

401(k) with employer match

Paid vacation and holidays

Job summary

Beta Bionics, Inc. in Irvine, CA seeks a production leader to oversee daily manufacturing operations, ensuring safety, quality, and on-time delivery while driving continuous improvement across the plant.

You will supervise production staff, partner with Quality, Engineering, and Supply Chain, and foster development of the team to meet customer demand and regulatory requirements in a fast-paced, regulated environment.

Qualifications

• 3–5 years of manufacturing experience in a regulated environment.
• 1–3 years of supervisory or team leadership experience.
• Experience with FDA, ISO 13485, GMP or similar quality systems preferred.
• Knowledge of manufacturing processes and production operations.
• Understanding of quality systems and regulatory requirements.
• Strong problem-solving and root-cause analysis abilities.
• Excellent organizational and time management skills.

Responsibilities

• Supervise daily production operations to meet safety, quality, delivery, and productivity goals.
• Lead, coach, and develop production employees through training and feedback.
• Monitor schedules, staffing, and workflow to maximize efficiency.
• Ensure compliance with FDA, ISO 13485, GMP and SOPs.
• Drive continuous improvement initiatives to boost productivity and quality.
• Collaborate with Quality, Engineering, Supply Chain, Maintenance and other teams to resolve issues.
• Maintain production records and communicate status and improvements to management.
• Support audits and investigations, CAPAs, and corrective actions.

Skills

Manufacturing processes

Quality systems

Leadership

Communication

ERP systems

Problem solving

Education

Associate/Bachelors in Manufacturing

High School Diploma

Tools

MS Office

ERP systems

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:

Responsible for leading daily manufacturing operations to ensure production targets, quality standards, safety requirements, and delivery commitments are consistently achieved. Supervises production personnel, drives operational efficiency, maintains compliance with Quality Management System requirements, and promotes a culture of continuous improvement.

Work closely with Quality, Engineering, Supply Chain, and other cross-functional teams to support safe, compliant, and efficient manufacturing operations while fostering employee development and engagement.

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]

• Supervise daily production operations to ensure safety, quality, delivery, and productivity goals are achieved.
• Lead, coach, and develop production employees through training, performance feedback, and accountability.
• Monitor production schedules, staffing, and workflow to maximize efficiency and meet customer demand.
• Ensure compliance with FDA, ISO 13485, GMP, company policies, Standard Operating Procedures (SOPs), and Work Instructions (WIs).
• Drive continuous improvement initiatives by identifying opportunities to improve productivity, quality, and operational efficiency.
• Collaborate with Quality, Engineering, Supply Chain, Maintenance, and other cross-functional teams to resolve production issues and support new product introductions.
• Monitor production metrics and implement corrective actions to achieve departmental Key Performance Indicators (KPIs).
• Promote a safe working environment by enforcing safety policies and proactively addressing workplace hazards.
• Maintain accurate production records and communicate operational status, issues, and improvement opportunities to management.
• Support internal, customer, and regulatory audits, and assist with investigations, CAPAs, and implementation of corrective actions.
• Perform other duties as assigned.

Required Education and Experience

Knowledge, Skills & Abilities

• Knowledge of manufacturing processes and production operations.
• Understanding of quality systems and regulatory requirements in a regulated manufacturing environment.
• Strong leadership, coaching, and conflict-resolution skills.
• Excellent organizational and time management skills.
• Strong problem-solving and root cause analysis abilities.
• Ability to prioritize multiple tasks and adapt to changing production demands.
• Effective verbal and written communication skills.
• Proficiency in Microsoft Office and ERP systems.
• Ability to interpret production metrics and implement performance improvements.

Minimum Certifications/Educational Level

• High School Diploma required.
• Associate's or Bachelor's degree in Manufacturing, Engineering, Business, or a related field preferred, or equivalent experience.

Minimum Experience

• 3–5 years of manufacturing experience, preferably in the medical device or another regulated industry.
• 1–3 years of supervisory or team leadership experience preferred.
• Experience leading teams in a fast-paced production environment.
• Experience with FDA, ISO 13485, GMP or similar quality systems is preferred.

Work Schedule

• Shift: 4th Shift
• Scheduled Hours: 5:00 PM – 5:00 AM
• Workdays: Friday, Saturday, and Sunday
• This position may require occasional overtime, schedule adjustments, or additional weekday coverage based on business needs, production demands, training, or operational requirements.

Work Environment and Personal Protective Equipment

• Works in a Lab, Clean Room, and Warehouse environment, within a well-lighted work area with good ventilation and normal noise levels from lab, shop equipment, and clean room. Personal Protective Equipment may be required for laboratory or field work.

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

$75,000 - $100,000

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.