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3 дня назад

Sr Engineer Design (Medical Devices)

101 000 - 152 000$
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
Sr Engineer Design (Medical Devices): Leading the design and development of innovative medical devices through CAD modeling, prototyping, design controls, and regulatory documentation with an accent on human factors, manufacturability, and cross-functional product development. Focus on transferring designs from R&D to manufacturing, managing risk and validation activities, and solving complex design and manufacturing issues for Class II devices.

Location: Hybrid role based in Northfield, Illinois, United States; travel up to 10% domestically and internationally.

Salary: $101,000–$152,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a worldwide medical device and healthcare organization developing and manufacturing regulated products.

What you will do

  • Lead medical device design initiatives by creating CAD models, prototypes, PCB layouts, and technical documentation.
  • Translate user needs into design specifications while integrating human factors, user-centered design, and regulatory requirements.
  • Coordinate cross-functional work with product management, clinical, regulatory, quality, manufacturing, and legal teams.
  • Drive design transfer from R&D to manufacturing through validation builds, process development, troubleshooting, and design reviews.
  • Manage project timelines, resources, milestones, product improvements, root cause analysis, risk assessments, and post-market feedback.
  • Mentor junior engineers and contribute to innovation pipelines and intellectual property strategy.

Requirements

  • Bachelor’s degree in mechanical engineering, biomedical engineering, electrical engineering, or a related technical field.
  • At least 4 years of experience in product design, preferably in medical devices or another regulated industry.
  • Advanced proficiency in SolidWorks or equivalent 3D CAD software, including prototyping, design documentation, and design for manufacturability.
  • Experience with structured product development processes, design controls, risk management, and cross-functional collaboration.
  • Knowledge of manufacturing processes including injection molding, machining, and assembly.
  • Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, FMEA, DHF, DMR, and traceability matrices.

Nice to have

  • Certified SolidWorks Professional certification.
  • Experience developing and launching Class II medical devices.
  • Recognized contribution to intellectual property and patent development.

Culture & Benefits

  • Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
  • Continuing education and training opportunities.
  • Resources supporting inclusion, belonging, and career growth.
  • Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access where applicable.

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