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Sr. Product Development Engineer-Shoulders (Medical Devices)

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
Sr. Product Development Engineer-Shoulders (Medical Devices): Developing surgical instruments and implants for total shoulder arthroplasty with an accent on 3D CAD design, design documentation, verification and validation, and FDA/ISO compliance. Focus on translating surgeon requirements into technically sound products, defining testing requirements, and coordinating cross-functional development from proposal through final design release.

Location: Austin, Texas, United States; on-site work across office, manufacturing, mechanical testing, and cadaver lab environments

Company

hirify.global is a medical technology company developing orthopedic products, services, and integrated technologies to improve patient outcomes and restore movement.

What you will do

  • Contribute to new product development projects from proposal through final design and release.
  • Translate surgeon requirements and product characteristics into designs for total shoulder arthroplasty instruments and implants.
  • Develop concepts and mechanisms using 3D modeling in SolidWorks and review designs for feasibility, accuracy, and technical soundness.
  • Create and maintain risk assessments, design reviews, engineering drawings, test plans, design verification and validation records, and Design History Files.
  • Define testing requirements and support compliance with FDA, ISO, and internal procedures.
  • Collaborate with manufacturing, supply chain, quality assurance, regulatory, marketing, and other engineering functions while maintaining project schedules and budgets.

Requirements

  • At least 8 years of design and development experience.
  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or an equivalent discipline.
  • Experience with 3D CAD packages; SolidWorks is preferred.
  • Knowledge of word processing, spreadsheet, internet, contact management, and change management software.
  • Must already have full-time work authorization in the United States and be able to maintain it without current or future visa sponsorship.
  • Ability to analyze data, define problems, prepare detailed test protocols and reports, and communicate with managers, customers, surgeons, and regulatory stakeholders.

Nice to have

  • Experience in medical devices, orthopedics, or another regulated industry.
  • Engineering co-op or internship experience.
  • Experience presenting technical information and responding to customer, regulatory, or design surgeon inquiries.

Culture & Benefits

  • Collaborative, cross-functional product development environment focused on scientific excellence and continuous improvement.
  • Participation in surgeon symposia, focus groups, consultant meetings, and cadaver labs.
  • Medical, dental, and vision insurance.
  • Spending and savings accounts, 401(k), vacation, sick leave, holidays, income protection plans, discounted insurance rates, and legal services.
  • Approximately 10% travel is required.

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