1 день назад
Mechanical Engineer (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Mechanical Engineer (Medical Devices): Supporting design changes, troubleshooting production and field issues, and improving the manufacturability and performance of respiratory medical devices with an accent on 3D CAD documentation, engineering analysis, and regulatory compliance. Focus on root-cause investigation, verification and validation testing, risk management, and post-market surveillance and CAPA activities.
Location: Sandpoint, Idaho, United States; Workplace: On-site
Company
is a Swiss-American medical device company developing non-invasive respiratory monitoring and therapeutic solutions for healthcare professionals.
What you will do
- Lead and support design changes and engineering updates for existing respiratory medical devices.
- Collaborate with cross-functional teams on product and manufacturing improvements.
- Create and manage 3D CAD models, drawings, specifications, and bills of materials.
- Conduct tolerance stack-ups, material selection, design for manufacturing and assembly, and other engineering analyses.
- Investigate root causes, perform failure analysis and testing, and support post-market surveillance and CAPA activities.
- Support verification, validation, risk management, and compliance with applicable medical device standards and regulations.
Requirements
- Bachelor’s degree in mechanical engineering preferred, or equivalent work experience.
- At least 3 years of experience as a Mechanical Engineer; medical device experience is preferred.
- Proficiency with 3D CAD tools such as SolidWorks or Creo.
- Strong knowledge of mechanical fundamentals, including GD&T, tolerance analysis, DFM/DFA, and materials.
- Familiarity with ISO 13485 and FDA design controls preferred, with the ability to develop working knowledge of applicable standards and regulations.
Culture & Benefits
- Meaningful work supporting respiratory care and patient outcomes.
- Opportunities for professional and personal growth and advancement.
- Medical, dental, and vision coverage.
- HSA, FSA, and 401(k) matching.
- Paid parental leave, wellness stipend, and tuition reimbursement.
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