Spinal Singularity (YC W16) Is Hiring a Medical Device R&D Engineer

We are seeking an experienced, versatile, medical device engineer to lead product R&D efforts for Spinal Singularity Inc. This position will be full-time employment based out of our headquarters in Orange County, CA. As the lead R&D engineer, you will assume responsibilities for all aspects of design, development, and project management.

KEY RESPONSIBILITIES: Iterative design, prototyping, and testing of an advanced, fully internal, extended-use urinary catheter system (FDA Class II). Define and fulfill product design requirements and specifications based on user needs, clinical considerations, regulatory requirements, and risk management strategies. Lead a team of engineers, vendors, and contract manufacturers. Manage engineering project timelines, budgets, and vendors. Thoroughly document the design process in accordance with design controls and other relevant internal SOPs. Coordinate the transition from design to manufacturing in adherence with Good Manufacturing Practice (GMP). Formulate, execute, and document the design verification & validation testing plan for regulatory submission of an FDA Class II medical device.

REQUIRED QUALIFICATIONS Bachelor's degree in engineering, scientific, or technical discipline. 6+ years of engineering experience, including 4+ years in the medical device industry. Extensive experience with medical device design and product development processes, including definition of product requirements, design reviews, risk management, failure modes & effects analysis (FMEA), and maintenance of a design history file. Thorough understanding of quality management systems and Good Manufacturing Practice (GMP) guidelines for medical devices. Fluency with computer-aided design (CAD) software (Solidworks). Extensive knowledge of medical implant-grade materials and corresponding rapid prototyping and manufacturing processes.

PREFERRED QUALIFICATIONS Familiarity with competitive landscape of urological devices and standards of care. Detailed knowledge of urological anatomy & physiology. Experience with urological and/or cardiovascular catheters and stents. Experience in the design of endoscopic and/or minimally invasive surgical tools. Experience interacting directly with the FDA, including pre-submission meetings, post-submission communications, and/or site audits. Working knowledge of reimbursement strategies and medical device stakeholder (patient-provider-payer) dynamics. Above all else, we seek an exceptional individual who can deliver results in an efficient and timely manner. The position will afford freedom to operate and execute within the bounds of the company's strategic plan, as well as the opportunity to be a stakeholder and instrumental player in an early-stage company. If you are a leader looking to solve complex medical challenges that affect millions of Americans, then consider applying!

To apply, please submit your resume and cover letter to info@spinalsingularity.com