Device Development Specialist

2 days ago

Brisbane, Queensland, Australia beBeeDevelopment Full time US$175,000 - US$250,000

Job Title: Device Development Professional

About the Role:

We are seeking an experienced professional to support device and combination product development activities. This critical role is responsible for developing strategic roadmaps, leading human factors evaluations, and ensuring regulatory compliance.

Responsibilities:

  • Develop strategic plans for biologic/device combination product development.
  • Lead human factors development activities to ensure usability and patient safety.
  • Author and review human factors/usability engineering plans and risk management documentation.
  • Collaborate with cross-functional teams to ensure successful project delivery.
  • Provide technical leadership and expertise in drug delivery technologies and device design.
  • Manage multiple projects simultaneously, ensuring adherence to timelines and budgets.
  • Ensure compliance with all relevant regulatory requirements throughout the product lifecycle.
  • Support packaging development for combination products.
  • Demonstrate expertise in prefilled syringe and autoinjector product development.

Qualifications:

  • Bachelor's degree in biomedical engineering, mechanical engineering, or related field.
  • Over 8 years of experience in drug product device development, with a proven track record of successful product launches.
  • Background in leading human factors formative and summative evaluations, including study oversight and authoring of plans and reports.
  • Demonstrated knowledge of regulatory requirements and industry best practices.
  • Extensive experience with the development and commercialization of prefilled syringes and autoinjectors.

What We Offer:

  • Total compensation package that is market competitive.
  • Annual performance incentive bonus.
  • New hire equity.
  • Ongoing performance-based equity.
  • Variety of benefits offerings, including medical, dental, and vision insurance, 401k match, flexible time off, and paid holidays.

Notice to Recruiters/Staffing Agencies:

Please do not contact us through this page. All recruitment vendors must have a fully executed, formal written agreement on file.

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