Senior Product Development Engineer
Based in San Diego, CA, Biological Dynamics, Inc. (BioDyn)is a privately held molecular diagnostics company, and a pioneer in the field of Alternating Current Electrokinetics (ACE) based diagnostics. At BioDyn, we are developing novel diagnostic solutions to screen, diagnose, and manage high burden conditions such as cancer. Our diverse team shares a passion for improving patient care, a focus on cutting-edge technology, and a deep commitment to innovation which shapes the future of our company and drives our innovative culture. To learn more about BioDyn, please visit our website at www.biologicaldynamics.com, or view a TEDx Talk given by our co-founder and CEO, Raj Krishnan, at https://goo.gl/5pi3eA.
We are currently seeking a full-time Senior Product Development Engineer to design and develop our in vitro diagnostic medical products intended for use in cancer treatment response monitoring, early cancer detection, and general disease diagnostics. As a member of our dynamic Product Development team, you will have a unique opportunity to design cutting-edge diagnostic solutions and bring them to market. The ideal candidate should have experience in medical device mechanicaldesign, and background in a variety of scientific and engineering disciplines as to encompass the broad scope of design challenges he/she will face. The individual in this position will work as a part of a team of engineers and scientists at the interface of microelectronics and molecular biology, developing novel devices for disease diagnostics and treatment monitoring.
RESPONSIBILITIES include the following:
• Product realization
• 2D and 3D computer-aided design (CAD) and modeling
• Design for manufacturability and tolerance analysis
• Formulation, tuning, and testing of design requirements and specifications
• Verification and validation testing
• Risk management and usability engineering
• Hands on troubleshooting, root cause analysis, corrective action, solution implementation
• Rapid fabrication and evaluation of prototypes
• Liaising with technicians and manufacturers to ensure design feasibility and economic viability
• Solving problems via close interaction with research, assay development, manufacturing, quality, and commercial operations departments
• Industrial design
• Design transfers to contract manufacturers and supplier management
• Other duties as assigned
• BS in mechanical engineering, bioengineering, or related field; MS or MEng preferred
• At least 5 years of medical device design experience
• Advanced proficiency with Solidworks and/or Autodesk Inventor and AutoCAD
• Experience taking products through safety testing such as IEC 61010 or 60601
• Experience working under design controls (e.g. 21 CFR 820or ISO 13485)
• Experience working under risk management (e.g. ISO 14971)
• Excellent oral and written communication skills, and a demonstrated ability to learn and communicate complex medical topics.
• Proficiency in the use of PowerPoint, Word, Excel, and Google Slides, Docs, and Sheets.
• Possesses a can-do positive attitude, which is a must!
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual may be required to sit; use hands to touch, handle, or feel and reach with hands and arms. He/she may occasionally be required to stand and/or move about the office and/or laboratory. Specific vision abilities may be required by this job including close vision and ability to adjust focus. Travel up to 10% may be required.
The successful candidate will join a dynamic, innovative team focused on developing cutting edge technologies in a fast-paced, collaborative environment. We offer a positive, diverse, and exciting work environment with competitive pay structures and benefits. Biological Dynamics is an equal opportunity employer. To apply for this position, please email your cover letter and resume.