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3 дня назад

Senior Electrical Manufacturing Engineer (PCBA)

97 000 - 165 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Electrical Manufacturing Engineer (PCBA): Developing, validating, and improving complex PCBA manufacturing processes for regulated insulin delivery medical devices with an accent on SMT, soldering, process qualification, quality compliance, and supplier oversight. Focus on leading NPI programs, solving high-impact manufacturing failures, managing risk under FDA and ISO requirements, and mentoring cross-functional engineering teams.

Location: On-site in Northridge, California, United States of America; occasional travel to supplier sites, contract manufacturers, or global facilities of up to 15–20%.

Salary: $97,000–$165,000 USD annually for California roles.

Company

hirify.global develops insulin delivery systems, predictive diabetes insights, and related support technologies for people living with diabetes.

What you will do

  • Lead the design, development, validation, qualification, and continuous improvement of complex PCBA manufacturing processes, including SMT, through-hole, reflow, wave, selective soldering, cleaning, and inspection.
  • Own IQ/OQ/PQ validation, process control plans, FMEAs, risk controls, SPC, capability improvements, and root cause investigations.
  • Lead PCBA manufacturing engineering for NPI programs from concept through production transfer, including readiness reviews, pilot builds, ramp activities, and manufacturing risk assessments.
  • Collaborate with R&D, design engineering, Quality, Supply Chain, and Regulatory teams on PCB layout, component selection, assembly design, supplier issues, and process changes.
  • Lead supplier and contract manufacturer qualification, audits, technical reviews, and ongoing performance oversight.
  • Mentor engineers, technicians, and operators; lead technical and design reviews, process audits, training, and continuous improvement initiatives using Lean, Six Sigma, kaizen, value stream mapping, automation, and digitalization.

Requirements

  • 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 PCBA manufacturing engineering and complex process development, qualification, and validation.
  • Ability to lead cross-functional teams, influence without direct authority, manage multiple priorities, and collaborate across R&D, Quality, Supply Chain, and Regulatory functions.
  • Strong analytical, problem-solving, written communication, verbal communication, presentation, mentoring, and project management skills.
  • Ability to work in office-based engineering and hands-on production floor environments, including clean room and ESD-controlled areas.
  • Preferred experience includes 8–12+ years in PCBA manufacturing engineering and 5 years in a regulated medical device, aerospace, or defense manufacturing environment.
  • Preferred technical expertise includes SMT and through-hole assembly, IPC-A-610 and J-STD-001, reflow, wave and selective soldering, AOI, X-ray and SPI inspection, DFM/DFA, IQ/OQ/PQ, FDA 21 CFR Part 820, ISO 13485, FMEA, ISO 14971, 8D, 5-Why, DOE, SPC, conformal coating, and cleaning processes.
  • Preferred knowledge includes ERP/MES systems such as SAP or Oracle, contract manufacturer management, RoHS, REACH, environmental compliance, AOI programming, Industry 4.0, Smart Manufacturing, and ESD control programs.
  • Preferred experience includes implantable or active medical devices and support for FDA inspections or Notified Body audits.

Nice to have

  • Master’s degree in Electrical Engineering, Manufacturing Engineering, or a related field.
  • IPC-A-610 Certified Trainer or IPC Specialist certification.
  • Six Sigma Green Belt or Black Belt certification.
  • PMP certification.

Culture & Benefits

  • Fast-paced, highly collaborative medical device manufacturing environment focused on technologies that improve patient outcomes.
  • Full-time employment with health, dental, and vision insurance, HSA and healthcare FSA access, life insurance, disability coverage, and dependent daycare spending account.
  • Paid time off and holidays, 401(k) with company match, incentive plans, Employee Stock Purchase Plan, Employee Assistance Program, and other eligible retirement benefits.
  • Work includes office-based engineering, production floor activities, clean room operations, and ESD-controlled manufacturing.

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