Principal Engineer - Automation & Assembly (Medical Devices)
Контакты
116 000 - 174 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
automationplcassemblyroboticsvalidationroot cause analysismanufacturing engineeringmachine visionmedical devices
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Зарплата и рынок
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$116к-174к/год
$130к$160кмедиана$170к
По похожим ролям (50) ~ $160к/год
На СНГ рынке: $3.1к/мес ($2.5к - $3.5к)
87
Хорошая вакансия
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Чёткая роль ведущего инженера охватывает проектирование оборудования, запуск, валидацию и улучшение производства в регулируемой сфере медицинских изделий.
Полный цикл проектов
Медицинские технологии
Понятные обязанности
?Работа на площадке
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Principal Engineer - Automation & Assembly (Medical Devices): Designing, commissioning, validating, and optimizing automated assembly equipment and manufacturing processes for a regulated medical device environment with an accent on capital equipment projects, equipment qualification, process validation, and production launch. Focus on leading complex automation initiatives, solving equipment and process performance issues, integrating PLCs, robotics, vision, and controls, and mentoring engineering teams.
Location: Glens Falls, New York, United States; on-site. Up to 10% business travel, including supplier visits, equipment acceptance activities, and domestic or international project support.
hirify.global is a growing worldwide medical device and healthcare products organization offering total rewards, continuing education, and training.
What you will do
Provide technical leadership for advanced automation, assembly equipment, manufacturing processes, and new product or equipment introductions.
Lead automated equipment projects from concept and machine design through supplier selection, build, factory acceptance testing, installation, commissioning, validation, production release, and optimization.
Develop project scopes, technical requirements, specifications, budgets, schedules, risk assessments, and implementation plans for capital equipment projects.
Author, review, and execute equipment and process validation documentation, including IQ, OQ, PQ, protocols, test methods, acceptance criteria, deviations, and reports.
Troubleshoot complex equipment, controls, quality, safety, and performance issues; lead root cause analysis and corrective actions.
Partner with Quality, Operations, Maintenance, R&D, suppliers, system integrators, and machine builders while mentoring engineers and technical team members.
Requirements
Bachelor’s degree in mechanical, electrical, automation, manufacturing, mechatronics, biomedical, or another engineering-related field, or equivalent knowledge and experience.
At least 7 years of engineering experience supporting automation, automated manufacturing equipment, assembly systems, machine design, equipment implementation, or manufacturing/process engineering.
Experience commissioning, proving out, validating, and bringing complex automated equipment or manufacturing processes into production.
Experience providing technical leadership, mentoring engineers, or leading cross-functional engineering projects.
Strong hands-on knowledge of automated equipment, machine systems, manufacturing processes, and structured technical problem solving.
Ability to manage capital projects, equipment suppliers, technical requirements, schedules, risks, and multiple priorities.
Working knowledge of equipment and process validation, technical documentation, change control, root cause analysis, and process improvement methods.
Excellent organizational, analytical, communication, collaboration, and problem-solving skills, with a humble, collaborative, and practical leadership style.
Nice to have
10+ years of direct automation-related experience in a manufacturing environment.
Experience with medical devices, healthcare products, pharmaceuticals, or other regulated manufacturing environments, including Class I or Class II medical devices, design controls, risk management, CAPA, change control, and quality-system requirements.
Hands-on knowledge of PLC programming and industrial controls, including Allen-Bradley platforms.
Experience with robotics, machine vision, servo or motion control, sensors, HMIs, safety systems, data acquisition, and manufacturing equipment integration.
Experience taking automated equipment from design and commissioning through validation, production launch, and sustained operation.
Experience leading CapEx projects with machine builders, systems integrators, and equipment suppliers.
Experience developing or validating machines, assembly processes, manufacturing methods, and products.
Experience with Lean, Six Sigma, Design of Experiments, process characterization, statistical analysis, or Minitab.
Formal leadership experience or success mentoring, teaching, and developing less-experienced engineers and technical personnel.
Culture & Benefits
Full-time, on-site employment in a regulated medical device manufacturing environment.
Competitive total rewards package with health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
Continuing education and training opportunities.
Inclusive workplace focused on belonging, diversity, and career growth.
Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access; benefit eligibility varies by average weekly hours.
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