Careers

Principal Device Engineer

About Aura:

At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies

We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases. Leveraging our VDCs’ broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication

Position Summary:

As a Biomedical Engineer in the Medical Device Department, you will work to support the development of drug delivery devices and drug activation laser that are essential to administer Aura’s innovative therapeutic treatments to cancer patients. This role will include working on innovative biologic/drug/device combination products and supporting several activities in the device department including product development, project management, clinical operations, and the creation of design history file documentation to satisfy medical device design control regulatory requirements.

Responsibilities include but are not limited to:

  • Working with Clinical Development, Research, Quality, and CMC departments to develop design requirements and the scope, costs and timelines to meet those requirements.
  • Plan, execute and analyze the results of medical devices performance testing to characterize and optimize device performance for relevant devices.
  • Assist in the creation of documents to support regulatory submissions and market approval of Aura’s combination products.
  • Creating engineering design documentation to support the creation of medical device design history files to satisfy 21 CFR 820 and ISO 13485 requirements.
  • Collaborate with internal Aura staff to ensure relevant development/compatibility studies are completed to support Aura’s clinical trials and marketing applications in all desired countries/regions.
  • Work with medical device vendors and consultants to design and develop drug medical devices to support drug delivery and medical laser light delivery programs.
  • Manage, procure, and maintain all test, laboratory and analytical equipment associated with medical device testing.
  • Developing and maintaining device risk management files.
  • Performing other duties as necessary.

Qualifications:

  • BS/BA in Engineering bachelor’s degree required; advanced degree (i.e. MS, PhD) preferred.
  • At least 5 years of experience and demonstrated success in medical device development including direct experience with design control, change control, clinical development and regulatory submissions; knowledge of pharmaceutical drug development a strong plus given Aura’s combination products.
  • Experience and solid understanding of the requirements for design controls, biocompatibility, extractable/leachable, packaging, and human factors studies.
  • Knowledge of device development guidances and regulations, including, but not limited to, 21CFR parts 081, 803, 807, 814, 820 and ISO Standards such as 13485, 14155, and IEC 80001 and 80002.
  • Strong project management skills and ability to work in a matrixed team environment.
  • Ability to work effectively with external vendors to manage expectations, timelines, and budgets to support Aura’s drug development needs.
  • Ability to multitask and oversee the simultaneous development of multiple devices and to successfully manage the relationship with multiple device vendors.
  • Medical device Regulatory Affairs experience in US and EU, with rest-of-world (ROW) experience a plus.
  • Must have a “hands on” approach to getting work done and an entrepreneurial drive to help grow the device department.
  • Ability to travel to global device vendor sites and clinical sites.

Benefits and Perks:

Aura offers a great benefit package which includes:

  • Health insurance with FULL premium coverage
  • 401K with company match
  • Competitive Paid time off (PTO)
  • Company-paid short & long-term disability insurance and life insurance
  • Daily in-office lunch provided
  • Free parking

Interested?  Please apply via our LinkedIn page: https://www.linkedin.com/jobs/view/3065797155