Senior Production Engineer

Beta Bionics, Inc.; Irvine (CA); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical + Dental

HSA/FSA

401(k) match

Paid time off

Job summary

The Senior Production Engineer at Beta Bionics, Inc. in Irvine, CA will design, develop and implement manufacturing processes that meet product specifications while ensuring safety, quality, and regulatory compliance.

You will monitor process performance, drive improvements, troubleshoot equipment, and collaborate with engineering, quality, maintenance and supply chain to hit production goals in a fast-growing startup environment.

Qualifications

• Bachelor's degree in mechanical/biomedical engineering or related field.
• 5–8 years of medical device experience.
• Experience in FDA/GMP/ISO environment.
• Ability to read mechanical drawings and electrical schematics.
• Proficient with Microsoft Office and related online applications.
• Ability to work effectively in cross-functional teams.

Responsibilities

• Support GMP and quality objectives, and comply with ISO 13485.
• Ensure compliance with ISO 13485 and FDA 21 CFR Part 820.
• Develop process improvements to maximize production efficiency.
• Lead lean manufacturing initiatives.
• Troubleshoot equipment and use root cause analysis.
• Collaborate with engineering, quality, maintenance and supply chain.

Skills

QSRs/GMPs

Hand tools

Mechanical drawings

Electrical schematics

Microsoft Office

Cross-functional teamwork

Education

Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering or related field

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:

The Senior Production Engineer will design, develop and implement manufacturing processes and procedures that meet the specifications and requirements of the products. Ensuring that the production processes are efficient, cost-effective, safe and compliant with quality standards and regulations is imperative. As a key support for production, the engineer will monitor and analyze the performance of the production processes and equipment, identify and solve problems, implement improvements and innovations, and coordinate with other engineers, technicians, operators and managers to achieve the production goals. The engineer will also communicate with customers, suppliers and other stakeholders to ensure customer satisfaction 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.
• Ensure compliance with quality standards such as ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes and FDA 21 CFR Part 820 Quality System Regulation as well as safety regulations such as OSHA.
• Ensure that all regulatory and internal policies are followed.
• Makes decisions in a timely manner, based upon a mixture of analysis, wisdom, experience and judgment.
• Monitor and analyze key performance indicators such as yield, scrap, downtime, cycle time, etc. and take corrective actions as needed.
• Develop process improvements to effectively utilize equipment and materials to maximize production.
• Implement continuous improvement initiatives using lean manufacturing principles and tools.
• Troubleshoot and resolve technical issues with machinery, equipment, or software using root cause analysis and corrective action techniques.
• Coordinate multiple project activities concurrently to achieve timeline requirements; use resources effectively and efficiently while adjusting to changing priorities in a start-up environment.
• Collaborate with cross-functional teams such as engineering, quality, maintenance, and supply chain to support production goals.
• Ability to establish, build and maintain professional working relationships with all levels of staff, clients, suppliers and the public.
• Ability to work with minimal supervision.
• Excellent interpersonal, verbal and written communication skills. Meticulous attention to detail and meeting deadlines.
• Demonstrates accuracy, thoroughness and monitors own work to ensure quality.
• Practice and advocate good safety skills at all times.
• Special projects will require extended work hours and some travel may be required.
• Other duties as assigned.

Required Education and Experience

Knowledge, Skills & Abilities:

• Ability to apply principles outlined in Quality System Regulations (QSRs/GMPs).
• Ability to use basic hand tools such as drills, soldering irons, micrometers, calipers, etc.
• Ability to operate electrical and mechanical equipment and interpret results
• Must be able to read and interpret mechanical drawings and electrical schematics.
• Proficient with Microsoft Office and on-line applications.
• Ability to work well with others in a cross-functional team environment.

Minimum Certifications/Educational Level:

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

Minimum Experience:

• 5-8 years of experience in a medical device environment.
• Experience in Medical Device, or Consumer Electronics.
• Experience in FDA/GMP/ISO environment.

Work Environment and Personal Protective Equipment

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopier, and scanners.

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

$95,000 - $130,000

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.