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MiniMed

Develops automated insulin delivery systems

Senior Electrical Manufacturing Engineer

Manufacturing EngineeringPosted on Nov 11
Full-timeNorthridge, Los Angeles, CA, USA

About the Job

Requirements

  • A bachelor's degree and at least 4 years of relevant experience, or an advanced degree and at least 2 years of relevant experience.
  • Experience in a regulated medical device, aerospace, or defense manufacturing environment is preferred for the role's technical scope.
  • Demonstrated experience leading new product introduction programs and complex process validation activities.
  • Expertise in surface-mount technology and through-hole assembly processes.
  • Expertise in IPC standards, including IPC-A-610 and J-STD-001.
  • Expertise in reflow, wave, and selective soldering.
  • Expertise in automated optical inspection, X-ray, and solder paste inspection systems.
  • Expertise in design for manufacturability and design for assembly principles and application.
  • Expertise in IQ/OQ/PQ process validation.
  • Expertise in FDA 21 CFR Part 820 and ISO 13485.
  • Expertise in failure mode and effects analysis and risk management under ISO 14971.
  • Expertise in root cause analysis methods, including 8D, 5-Why, and design of experiments.
  • Expertise in statistical process control.
  • Expertise in conformal coating and cleaning processes.
  • Knowledge of Six Sigma and Lean Manufacturing.
  • Experience with enterprise resource planning and manufacturing execution systems, including SAP and Oracle.
  • Experience managing contract manufacturers.
  • Ability to lead cross-functional teams and influence without direct authority.
  • Project management skills and the ability to manage multiple priorities simultaneously.
  • Analytical and problem-solving capabilities using a data-driven approach.
  • Written and verbal communication skills, including presenting to senior leadership.
  • Ability to mentor and develop junior engineering talent.
  • Ability to collaborate across research and development, Quality, Supply Chain, and Regulatory teams.
  • A master's degree in Electrical Engineering, Manufacturing Engineering, or a related field is preferred.
  • IPC-A-610 Certified Trainer or IPC Specialist certification is preferred.
  • Six Sigma Green Belt or Black Belt certification is preferred.
  • Project Management Professional certification is preferred.
  • Experience with implantable or active medical devices, such as insulin pumps, neurostimulators, or cardiac devices, is preferred.
  • Knowledge of RoHS, REACH, and environmental compliance requirements is preferred.
  • Experience with automated optical inspection programming and optimization is preferred.
  • Familiarity with Industry 4.0 and Smart Manufacturing technologies is preferred.
  • Background in electrostatic discharge control program development and management is preferred.
  • Experience supporting FDA inspections or Notified Body audits is preferred.
  • Ability to work in a clean room and electrostatic discharge-controlled manufacturing environment.

Responsibilities

  • Lead the design, development, validation, and continuous improvement of complex printed circuit board assembly manufacturing processes, including surface-mount technology, through-hole, reflow soldering, wave soldering, selective soldering, and advanced cleaning.
  • Improve process capability using statistical methods and engineering techniques to achieve high yields and quality metrics.
  • Own and lead full process qualification and validation activities (IQ/OQ/PQ), from planning through execution and approval.
  • Develop and implement design for manufacturability and design for assembly guidelines, and ensure adoption by design engineering teams.
  • Lead root cause analysis for complex, recurring, or high-impact printed circuit board assembly manufacturing failures.
  • Evaluate, qualify, and implement new materials, equipment, and technologies to improve process performance and competitiveness.
  • Define and own process control plans, failure mode and effects analyses, and control strategies for critical printed circuit board assembly processes.
  • Serve as the primary printed circuit board assembly manufacturing engineering lead for new product introduction programs, from concept through full production transfer.
  • Lead manufacturing readiness reviews and ensure printed circuit board assembly processes are production-ready before launch.
  • Collaborate with research and development and design engineering teams during early-stage development to influence printed circuit board layout, component selection, and assembly design decisions.
  • Define pilot build strategies, process qualification plans, and production ramp activities.
  • Develop and present manufacturing risk assessments and mitigation strategies to program leadership.
  • Serve as the technical subject matter expert for printed circuit board assembly process-related topics across the organization.
  • Mentor and coach junior and mid-level manufacturing engineers, technicians, and operators.
  • Lead technical reviews, design reviews, and process audits with internal and external stakeholders.
  • Develop and deliver training programs on printed circuit board assembly processes, IPC standards, and quality requirements.
  • Represent manufacturing engineering in cross-functional core teams and program reviews.
  • Ensure printed circuit board assembly processes comply with IPC standards, including IPC-A-610, IPC-7711/7721, and IPC-J-STD-001, and medical device regulatory requirements.
  • Lead corrective and preventive action investigations and systemic corrective actions for printed circuit board assembly-related non-conformances and customer complaints.
  • Own process-level risk management activities in accordance with ISO 14971.
  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, and other applicable standards.
  • Support regulatory submissions, internal audits, and external inspections related to printed circuit board assembly manufacturing.
  • Drive implementation of statistical process control and key process indicators to monitor and control printed circuit board assembly process performance.
  • Lead qualification and ongoing oversight of contract manufacturers and printed circuit board assembly suppliers.
  • Conduct supplier audits and technical reviews to assess process capability and quality performance.
  • Define supplier quality requirements and collaborate with Supply Chain to resolve supplier-related printed circuit board assembly issues.
  • Evaluate and approve material and component changes from a manufacturing process perspective.
  • Champion Lean Manufacturing and Six Sigma methodologies to reduce waste and improve process efficiency.
  • Lead or participate in kaizen events, value stream mapping, and other continuous improvement initiatives.
  • Identify and implement automation and digitalization opportunities in printed circuit board assembly manufacturing processes.
  • Track and report yield, defect rates, cycle time, and other key printed circuit board assembly process metrics.
  • Perform office-based engineering work and hands-on production floor activities.
  • Travel occasionally to supplier sites, contract manufacturers, or global facilities, up to 15–20%.

About the Company

MiniMed

Develops automated insulin delivery systems

MiniMed develops insulin delivery and automated insulin delivery systems, plus related sensors, pens, and software. Its products couple glucose sensors with pumps or smart pens to automatically adjust insulin or simplify dosing. It differentiates itself with an integrated ecosystem of devices and software and a large share of recurring revenue from sensors, consumables, software and services across more than 80 countries. Its goal is to be a leading global provider of insulin delivery and glucose monitoring solutions that help people with diabetes achieve better glycemic control.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Los Angeles, CA
Founded
1983

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