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10 дней назад

Project Engineer (Medical Devices)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
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TL;DR
Project Engineer (Medical Devices) (CREO/SolidWorks): Developing surgical instruments and implants from concept through commercialization, while supporting the lifecycle of medical products with an accent on CAD design, design verification, FDA-compliant documentation, and customer feedback. Focus on coordinating cross-functional engineering changes, supporting clinical evaluations in operating rooms and cadaver labs, and improving product performance and manufacturability.

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies, surgical instruments, and implants for patients with musculoskeletal disorders.

What you will do

  • Lead the CAD design and development of surgical instruments and implants using CREO and/or SolidWorks.
  • Manage projects from concept through commercialization, including project plans, Design History Files, verification, validation, and regulatory documentation.
  • Coordinate prototyping and evaluation with internal prototype shops and external vendors.
  • Engage surgeons and customers through product introductions, customer visits, sales training, and support for surgical cases.
  • Collaborate with Marketing, Product Management, Operations, Quality, Regulatory, Manufacturing, and Supply Chain teams.
  • Support commercialized products through quality improvements, supply chain changes, cost initiatives, design updates, and documentation revisions.

Requirements

  • Bachelor’s degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a related field.
  • At least 3 years of mechanical design engineering experience; medical device experience is strongly preferred.
  • Proficiency with CREO and/or SolidWorks, CAD-based mechanical design, and technical documentation.
  • Proficiency with Microsoft Excel, PowerPoint, and Project.
  • Strong analytical, problem-solving, communication, organizational, and collaboration skills.
  • Ability to work in engineering and clinical environments, including operating rooms and cadaver labs, and meet the listed physical requirements.

Culture & Benefits

  • Culture centered on innovation, customer focus, teamwork, and drive.
  • Work involves collaboration with researchers, educators, surgeons, healthcare providers, suppliers, and cross-functional teams.
  • Commitment to ethical business practices, regulatory compliance, inclusion, and equal employment opportunity.
  • Reasonable accommodations are available for individuals with disabilities.

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