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Engineering Manager - New Product Development (Medical Devices)

Формат работы
hybrid
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
Engineering Manager - New Product Development (Medical Devices): Leading the development and commercialization of orthopedic knee products with an accent on engineering team leadership, 3D mechanism design, regulatory documentation, and design verification and validation. Focus on managing cross-functional product development, coordinating testing and manufacturing suppliers, and ensuring product safety, quality, performance, and cost requirements.

Location: Austin, Texas, USA; in-office work required Tuesday through Thursday. Additional in-office work may be required for surgeon customer interactions. Travel is less than 15%.

Company

hirify.global develops clinically differentiated medical technologies and orthopedic products designed to improve patient outcomes and restore movement.

What you will do

  • Lead biomedical, mechanical engineering, and engineering technician teams developing and commercializing orthopedic knee products.
  • Translate surgeon requirements into product characteristics, engineering specifications, designs, and project plans.
  • Develop concepts and mechanisms using 3D CAD, including NX, and review designs for feasibility and technical soundness.
  • Manage design verification and validation, testing requirements, risk assessments, design reviews, and technical documentation.
  • Coordinate with manufacturing, purchasing, regulatory, supply chain, quality, surgeons, and external suppliers.
  • Manage project schedules, budgets, resources, hiring, mentoring, and product development process improvements.

Requirements

  • 10+ years of design and development experience.
  • Bachelor’s degree in Mechanical Engineering or equivalent.
  • Experience with 3D CAD packages such as SolidWorks, NX, or Pro/ENGINEER.
  • Ability to lead engineering personnel and manage product development projects.
  • Ability to prepare technical documentation, analyze data, define problems, and draw valid conclusions.
  • Must already have full-time work authorization in the United States without current or future visa sponsorship.

Nice to have

  • Experience with medical devices or orthopedics.
  • Previous experience managing engineering personnel.

Culture & Benefits

  • Collaborative work with engineering, manufacturing, regulatory, quality, business, and surgeon stakeholders.
  • Work across office, mechanical testing lab, manufacturing, and cadaver lab environments.
  • Medical, dental, and vision insurance.
  • Spending and savings accounts, 401(k), vacation, sick leave, and holidays.
  • Income protection plans, discounted insurance rates, and legal services.

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