Senior Manufacturing Automation Engineer

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.

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!

_{*User must be carb aware.}

Summary/Objective:

The Senior Manufacturing Automation Engineer plays a critical role in spearheading the design, implementation, and maintenance of automation solutions tailored specifically to the stringent standards of medical device production. The Senior Manufacturing Automation Engineer must demonstrate a profound understanding of regulatory compliance and possess extensive experience in developing automation systems within cleanroom settings, ensuring precision, reliability, and adherence to industry standards. Additionally, experience in managing supplier relationships, both locally and overseas, to procure components and establish demand expectations is crucial. The Senior Manufacturing Automation Engineer will work closely with cross-functional teams to drive continuous improvement, implement best practices, and enhance manufacturing capabilities. A strong understanding of Lean manufacturing principles and their application is required. The Senior Manufacturing Automation Engineer will be responsible for designing, analyzing, developing, and qualifying automated processes to meet manufacturing needs while enhancing productivity and product quality. Critical attributes and skills include technical creativity, initiative, ability to analyze problems, prioritize and negotiate priorities, use a hands-on practical approach, multi-tasking, and coordinating between groups within the company. Performs a variety of duties that involve engineering analysis and problem solving. Works with multiple cross-functional teams utilizing the Agile Scrum project planning process.

Note: This job description outlines the primary responsibilities and qualifications for a Senior Manufacturing Automation Engineer, and it is intended to provide a comprehensive overview and is not exhaustive. Other duties may be assigned as necessary to meet the evolving needs of the organization.

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]

• Required Skills:
  • Makes decisions in a timely manner, based upon a mixture of analysis, wisdom, experience and judgment.
  • Ability to work with minimal supervision.
  • Possesses meticulous attention to detail and meeting deadlines.
  • Demonstrates accuracy, thoroughness and monitors own and other’s work to ensure quality.
  • Demonstrates proficiency in CAD and parametric modeling.
• Automation Development and Improvement:
  • Proficiently design and program PLCs, HMIs, and SCADA systems, emphasizing precision, accuracy, and cleanliness, utilizing industry-leading software platforms such as Siemens TIA Portal and Rockwell Automation Studio.
  • Integrate robotics and vision systems seamlessly into manufacturing processes within cleanroom environments, maintaining strict adherence to quality control measures and cleanliness standards.
  • Lead the conceptualization, design, and deployment of automation systems optimized for medical device manufacturing within cleanroom environments, adhering to FDA QSR (Quality System Regulation) and ISO 13485.
  • Drive continuous improvement initiatives by identifying opportunities to automate manual processes, reduce cycle times, and enhance overall manufacturing efficiency within cleanroom constraints.
  • Conduct thorough risk assessments and validation procedures for automation systems, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) protocols, to ensure the robustness and reliability of manufacturing operations within cleanroom environments.
• Quality Management:
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations including compliance to ISO 13485 Medical Device Quality Standards.
  • Lead troubleshooting efforts for automation systems within cleanroom environments, collaborating with technical teams to diagnose and resolve issues promptly while upholding regulatory compliance and cleanroom protocols.
  • Develop and maintain comprehensive documentation, including equipment specifications, validation protocols, and standard operating procedures (SOPs), to support compliance and knowledge dissemination within cleanroom environments.
• Collaboration with Cross-Functional Teams:
  • Collaborate closely with interdisciplinary teams, including R&D, Quality Assurance, and Regulatory Affairs, to define automation needs, develop project plans, and execute strategies that align with regulatory standards and cleanroom protocols.
  • Coordinate with other departments to ensure seamless integration of supplier products and processes into the manufacturing workflow.
• Project Management:
  • Coordinate multiple project activities concurrently to achieve timeline requirements; use resources effectively and efficiently while adjusting to changing priorities in a start-up environment.
  • Plan, execute, and monitor automation projects from inception to completion, ensuring projects are delivered on time, within scope, and within budget.
  • Define project goals, objectives, and key performance indicators (KPIs) in alignment with overall company objectives.
  • Coordinate with cross-functional teams to allocate resources, set milestones, and establish project timelines.
  • Regularly communicate project status, risks, and mitigation plans to stakeholders and leadership.
• Continuous Improvement:
  • Lead and participate in cross-functional teams to drive continuous improvement initiatives in automated processes, product quality, and cost efficiency.
  • Implement and promote a culture of continuous improvement, fostering technical creativity and innovation among the team.
• Training and Mentoring:
  • Provide guidance and mentorship to junior engineers, fostering their professional growth and development.
  • Conduct training sessions for production operators on new processes and equipment.

Required Education and Experience

• Bachelor’s Degree in either Software, Electrical, Robotics, or similar field
• Minimum 7 years of experience in developing Automated Systems
• Minimum 3 years with a Medical Device Manufacturer or other regulated field

Work Environment and Personal Protective Equipment

• Professional office and manufacturing environments; occasional lab or field work requiring personal protective equipment.
• Personal Protective Equipment (PPE) may be required for specific tasks at Beta Bionics, including but not limited to safety glasses, gloves, lab coats, and hearing protection.

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 15% depending upon business needs.

Location

• This position is based out of our office in Irvine, California.

Salary Range

$100,000 - $140,000

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.