ABOUT US
Sorrento Therapeutics is a leading biotherapeutics pharmaceutical company with a mission to develop novel therapeutic approaches that extend and enhance cancer patients’ lives, either by reducing the malignancy of life-threatening tumors, improving the safety of current treatments, or by bringing novel solutions to make living with cancer more tolerable. Sorrento is based in San Diego, California, with world class antibody engineering capabilities and a robust early stage pipeline focused on immuno-oncology, infectious disease, and non-opioid pain.
The newly formed Sorrento Devices and Diagnostics Division is focused on developing and delivering breakthrough solutions for patients enabled by innovative medical devices. Sorrento Diagnostics and Connected Health is responsible for the design and commercialization of antibody-enabled diagnostics and connected health solutions. This is a particularly exciting and important moment in history as Sorrento brings a continuum of solutions in the battle against the COVID (and future) pandemics. Sorrento also is involved in other exciting innovative drug delivery technologies such as nano-particles and the Sofusa® (“soft infusion”) microneedle system. The proprietary nano-structured microneedle and microfluidics system are designed to access the tiny systemic and lymphatic capillaries just below the epidermis. (www.Sofusa.com).
Sorrento Therapeutics, Inc. is a federal government contractor and, in compliance with its obligations under current federal regulations, Sorrento requires all employees, including newly hired employees, to present proof of vaccination against COVID-19, unless the employee is legally entitled to an accommodation. For further information, please refer to the Safer Federal Workforce Task Force’s September 24, 2021 Guidance for Federal Contractors and Subcontractors, available at: https://www.saferfederalworkforce.gov/contractors/.
The Role: Senior Device Engineer, Diagnostics
Reports To: SVP, Diagnostics
Location: Sandy Springs, GA or San Diego, CA
WHAT YOU’LL DO:
Purpose of Role:
Lead technical design and development efforts for Sorrento’s emerging Diagnostics portfolio while building Sorrento capabilities for follow-on Diagnostics and Connected Health.
Essential Duties and Responsibilities
Design innovative lymphatic drug delivery devices from concept through successful transfer to manufacturing (design concepts, specifications, prototypes, testing, clinical supply chain, pre-clinical/clinical studies, transfer to manufacturing). Work collaboratively with management, regulatory, quality, and manufacturing to define device design and development objectives. Engineer Sofusa components and assemblies that initially meet requirements for human clinical Phase I/II trials, and ultimately meet requirements for Phase III clinical trials, FDA approval, and commercialization. Create Solidworks 3D models and 2D drawings, and create associated specifications throughout all stages of development from concept through commercialization. Perform designed experiments (DOEs), document results of feasibility studies and engineering evaluations in lab notebooks and technical reports, and author Design Verification protocols and reports. Execute and comply with Design Controls and lead Design Reviews with strong cross-functional input and collaboration. Ensure device design and development documentation meets all domestic and international regulatory submission requirements Create and manage Design & Development Plans, Traceability Matrices, Risk Assessments (Design, Use, & Process FMEAs), Design Verification and Validation Testing, Design History Files, etc. Work closely with Manufacturing and Quality to design assembly fixtures, inspection fixtures, and equipment, and to develop manufacturing processes and test methods Assures product quality by designing test methods and testing finished products and systems Ensure designs for the Sofusa device portfolio of products are informed by relevant product, user, and commercial needs. Lead in the assessment, selection, and management of device component suppliers required to accomplish device design and development objectives Participate in key cross functional activities in support of device development including pre-clinical CRO activities, human clinical CRO activities, protocol writing, IND submissions. Monitor the device competitive landscape and translate relevant threats and opportunities to the CTO and Platform Leader.
Other duties as assigned.
Work Environment
Will include manufacturing plants, distributor facilities, and office environment. Thus, while performing the duties of this job you may be required to intermittently sit, stand, walk, lift up to 25 pounds, lift in excess of 25 pounds with a lift assist, climb stairs, reach with hands and arms, stoop, kneel, crouch, bend at the waist, talk and hear.
EDUCATION AND QUALIFICATIONS:
Bachelor of Science degree (Mechanical, Biomedical Engineering preferred) Minimum of 5 years of experience (10 years preferred) in development and commercialization of diagnostics (experience with connected health is a plus) Demonstrated knowledge and success in design and development of engineering components for medical devices (CFR Part 820) Experience in diagnostic product development, clinical testing, and regulatory filings Knowledge of material science, mechanics, and transport phenomena (experience with CMOS manufacturing and microfluidics preferred) A team player who works effectively with other functions to solve problems in a way that meets both quality objectives and business goals Exceptional written and verbal communication skills. Communicates proactively and effectively. Able to present to senior leadership audiences with concise/relevant summaries. Excellent organizational and project management skills. Detail-focused with ability to multitask effectively and work efficiently within a strict timeline-driven environment. Have fun! Collaborate and learn with the Sofusa team while developing life-changing diagnostic solutions for patients.
YOUR REWARD:
Support scientists who are on the leading edge of immunotherapies for the treatment of cancer. Earn a competitive salary that allows you to focus your attention on your passion. A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and flexible PTO, plus stock options.
If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you!
Principals only. Recruiters, please don't contact this job poster.
Sorrento Therapeutics, Inc. is an Equal Opportunity Employer