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About the job
About CraniUS
CraniUS is a medical device research and development company based in Baltimore, MD. Our goal is to improve the treatment for patients with chronic brain disease through long-term convection-enhanced delivery directly to the brain, bypassing the blood-brain barrier. CraniUS is initially targeting glioblastoma multiforme, one of the deadliest forms of brain cancer, by surgically placing an implantable device that stores and delivers chemotherapy directly to the brain.
Job Description
The primary responsibility of the Director of Engineering is to direct the Mechanical Engineering and Hardware Engineering teams to invent, design, and deliver the mechanical systems and hardware systems for our implantable device and wireless charging platform that successfully meet our defined First-in-Human study design requirements. The Director of Engineering will report to and closely collaborate with the Chief Technology Officer, as well as closely collaborate with the Director of Software & Cybersecurity and VP of Strategy & Operations. The Director of Engineering will also be expected to support quality, regulatory, and intellectual property efforts, as requested.
Skills & Requirements
- Bachelor’s degree in mechanical engineering or equivalent engineering discipline
- Master’s degree in mechanical engineering or equivalent work experience
- Thrive in a collaborative, fast-paced, positive, supportive, evolving engineering environment
- Strong communication skills, risk identification skills, and project/timeline management skills
- Five to eight years of work experience in the following, or equivalent, areas:
o A successful mechanical engineer and hardware engineer; proficient in SolidWorks or other CAD software and Altium or other ECAD software
o A successful mechanical and hardware engineering team manager
o Experience in early-stage medical device innovation: an idea to the bench to bedside
- Ability to problem solve and develop creative solutions, both independently and collaboratively
- Experience with Quality Management Systems and familiarity with FDA and ISO regulations
- Experience with patent filings
- Strong technical writing and documentation skills
- Candidate must work in-person at the CraniUS office