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7 дней назад

Senior Mechanical Engineer (Medical Devices)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Sweden
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 Mechanical Engineer (Medical Devices) (SolidWorks/AAC devices): Designing and prototyping molded, sheet-metal, and machined hardware components for FDA Class II assistive communication devices with an accent on 3D CAD, design for manufacturability, and production readiness. Focus on developing complex parts and assemblies, presenting gated design reviews, managing engineering changes and risks, and moving products from concept through production.

Location: Stockholm, Sweden

Company

Develop assistive communication solutions that help people with disabilities express themselves, connect with the world, and live richer lives.

What you will do

  • Design molded plastic and metal components, sheet-metal parts, and machined components for AAC devices.
  • Generate parts, assemblies, and 2D drawings using SolidWorks, including complex solid and surface models.
  • Build prototypes and proof-of-concept solutions and support projects from concept through production launch.
  • Present gated design reviews and collaborate with mechanical, industrial, electrical, product, project, quality, sourcing, supplier, and manufacturing teams.
  • Participate in the ECO process, change management, risk management, BOM creation, and part-number development.
  • Work with manufacturing teams and suppliers, including the manufacturing group in China, to deliver programs on time and within budget.

Requirements

  • Bachelor’s degree in Mechanical Engineering and 5–10+ years of relevant experience.
  • Experience developing complex plastic and metal injection-molded components suitable for tooling and molding.
  • Experience with detailed part, assembly, and drawing development.
  • Proficiency with SolidWorks, 3D solid and surface modeling, and design for manufacturability and assembly.
  • Strong problem-solving and communication skills, experience in a fast-paced high-performance team, and the ability to maintain a safe working environment.
  • Proficiency with Microsoft Office and Teams.

Nice to have

  • Experience with FDA-registered Class II medical devices, AAC devices, ISO 13485, or IEC 60601.
  • Experience with CAD PDM data management and Arena or a similar QMS system.
  • Experience developing plastic injection-molding tools and electronics hardware.
  • Experience collaborating with teams in the USA, China, and Sweden.

Culture & Benefits

  • Work on products with a direct impact on customers’ ability to communicate.
  • Join a dynamic global company focused on innovation for good.
  • Collaborate in an environment where teamwork and individuality are valued.
  • Work with current technology and leading assistive communication platforms.
  • Benefit from flexibility that supports life outside work.

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