Medical Device Hardware Development Manager

7 days ago

Sydney, New South Wales, Australia beBeeDevelopment Full time $150,000 - $200,000
Job Title:

A Medical Device Hardware Development Manager is required to lead and assist teams in designing, developing, and testing innovative hardware solutions for medical devices.

About the Role:

This role involves owning the hardware development process, leading cross-functional teams to ensure successful product delivery, including software/firmware, quality, and regulatory. The ideal candidate will manage the development process, develop and maintain hardware requirements, specifications, and design documentation, conduct design reviews, and provide technical guidance to team members.

Main Responsibilities:

  • Lead the hardware development team to design, develop, and test hardware solutions for medical devices.
  • Work closely with cross-functional teams to ensure successful product delivery, including software/firmware, quality, and regulatory.
  • Manage the development process, including project planning, scheduling, and resource allocation.
  • Develop and maintain hardware requirements, specifications, and design documentation.
  • Conduct design reviews and provide technical guidance to team members.
  • Ensure that all hardware designs comply with relevant regulatory standards.
  • Investigate and resolve technical issues as needed.
  • Stay current with industry trends and emerging technologies in hardware development.
  • Mentor Junior Engineers and foster professional engineering practices including design documentation and traceability, compliance with applicable standards and V&V.

Requirements:

  • Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, or related field.
  • Minimum of 7 years of experience in hardware development, with at least 2 years of experience in a leadership role.
  • Experience with medical device development, including knowledge of regulatory requirements such as IEC 60601 and FDA requirements.
  • Experience with ISO 60601-1 safety and ISO 14971 risk management.
  • Excellent leadership skills and the ability to lead and motivate a team of engineers.
  • Strong project management skills, including the ability to develop project plans, allocate resources, and manage schedules.
  • Excellent communication skills, with the ability to communicate technical information to non-technical stakeholders.
  • Strong problem-solving and analytical skills.
  • Experience with simulation tools (Altium).
  • Ability to work in a fast-paced, dynamic environment with changing priorities.

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