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Sr. Systems Engineer (Medical Devices)

110 400 - 165 600$
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. Systems Engineer (Medical Devices): Developing new Neuromodulation products from early feasibility through to market release with an accent on system architecture, design specifications, and requirements engineering. Focus on translating customer needs into hardware and software specifications and ensuring compliance with FDA and ISO regulatory standards.

Location: Fridley, Minnesota, USA. Unrestricted U.S. work authorization required

Salary: $110,400 – $165,600

Company

hirify.global is a global leader in healthcare technology focused on alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

  • Transform customer and business needs into high-quality engineering requirements.
  • Perform system architecture and design across all development phases from concept to disposal.
  • Conduct functional analysis, trade studies, and interface definition to create hardware and software specifications.
  • Lead system analysis activities including performance modeling, system integration, and design failure modes and effects analyses (DFMEA).
  • Develop digital platform solutions and define data models for collecting, storing, and accessing information.
  • Verify and validate that implemented systems meet customer needs and regulatory requirements.

Requirements

  • Bachelor's degree with 4+ years of experience, Master's with 2+ years, or PhD.
  • Unrestricted U.S. work authorization at the time of hire.
  • Experience in system definition, requirements tracing, and V&V strategies.
  • Familiarity with medical device regulatory standards such as ISO, FDA 21CFR820.30, IEC-60601, and IEC-62304.
  • Ability to travel up to 10% for business events and product launches.

Nice to have

  • Experience with hardware/firmware communication interfaces and closed-loop feedback control systems.
  • Proficiency in developing data analytics and machine learning algorithms.
  • Experience architecting automated software integration solutions and DevOps CI/CD pipelines.
  • Background in cloud infrastructure and health software design.
  • Experience interfacing directly with physician customers and therapy consultants.

Culture & Benefits

  • Competitive base salary and eligibility for the hirify.global Incentive Plan (MIP).
  • Comprehensive health, dental, and vision insurance with HSA and Flexible Spending Account options.
  • 401(k) plan with employer contribution and matching.
  • Employee Stock Purchase Plan and tuition assistance/reimbursement.
  • Global well-being program (Simple Steps) and generous paid time off.

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