Product Development Engineer

We are looking for smart, curious, and passionate individuals to join our culturally diverse team and contribute to our shared success. Are you an engineer who knows about PCR or a molecular biologist who knows CAD?  Are you a smart, curious, and passionate person looking to use your skills to make an impact in a dynamic, culturally diverse and fast-growing company?   

We are seeking a Product Developer Engineer/Scientist to become an immediate and valuable contributor. Your role will be on our IVD team, helping to the design, develop, and commercialize the next generation of our groundbreaking diagnostic products. 

 

Essential Functions:

• Contribute to the design and development of medical diagnostic devices and consumables through all stages from concept to customer. 
• Optimize existing designs, materials and manufacturing processes to facilitate product improvement. 
• Participate in development of documentation to ensure compliance under 21 CFR Part 820. 
• Develop, perform and document test procedures for verification and validation. 
• Participate in design reviews and contribute to the risk management process. 
• Complete design drawings and models in Solidworks (or equivalent) and create prototypes to progress the development through its design stages. 
• Coordinate and assist in corrective and preventative action activities and solutions. 
• Communicate with strategic vendors and suppliers. 
• Any other duties applicable to the position.

Minimum Qualifications

• 4yr degree in applicable field of study, Engineering (Mechanical or Biomedical Engineering) or Analytical Biochemistry. 
• 2+yrs professional experience; salary will be commensurate with skills and background.   
• Experience working on regulated products under 21 CFR Part 820. 
• Good written and verbal communication skills. 
• Project management, self-starter and self-organizer. Excellent problem Solver. 

Biomeme was conceived and created to make the world a better place through the democratization of healthcare diagnostics. To that end, we have created technology that empowers anyone, anywhere (including low-resource settings with minimal space, electricity, and equipment) with the capabilities of a molecular lab in the palm of their hands. Over the last nine years, Biomeme has grown a vertically integrated organization spanning specimen collection, sample prep, assay, and instrumentation R&D, PCR reagent lyophilization, hardware, and consumable manufacturing, as well as molecular diagnostic testing services. With the low cost, ease-of-use, and unparalleled field portability of the Biomeme platform, we are uniquely poised to rapidly advance initiatives in emerging infectious diseases like COVID-19, as well as emergency preparedness, response, and recovery.