DNA Electronics (DNAe) · 6 days ago
Sr. Product Development Engineer
San Diego, CA
Contract
Onsite
Senior Level
$135K/yr - $150K/yr
7+ years expDNA Electronics (DNAe) is focused on developing revolutionary technology in the diagnostics field. The Senior Product Development Engineer is responsible for the design and integration of products, leading the development of test plans and ensuring performance requirements are met.
Biotechnology
Responsibilities
Successfully integrate assay, cartridge (consumable), instrument, and software components to support the development, transfer, verification/validation, and commercialization of new products
Collaborate with Core Team representatives from various departments to determine Design Inputs, translate inputs into Specifications and Design Outputs, optimize the design to meet required performance, and Verify/Validate product performance
Research, select, characterize, and optimize product components to meet system performance requirements
Develop test plans and test procedures for components at the unit, subsystem, and system levels, execute test plans, and generate reports for executed test procedures
Lead team in the generation of test procedures, execution of test protocols, and generating test reports
Develop/Optimize assay profiles in system and/or lab development software and optimize profile parameters to meet system performance requirements
Identify and implement design improvements
Troubleshoot and debug fluidic, mechanical and control system problems
Gather and analyze data to establish and characterize system requirements and system performance
Demonstrate abilities to follow protocols and workflow instructions
Working knowledge of regulatory and safety standards a plus
Other duties as assigned
Qualification
Required
Bachelor's degree in an Engineering, Chemistry, Biology, or closely related discipline
Strong presentation and influencing skills and outstanding verbal, written, and documentation skills are required
Excellent collaboration and interpersonal skills to work well with scientists and engineers having widely divergent backgrounds
Strong organizational skills and ability to organize work for multiple people
Comfortable working in a fast-paced, dynamic environment while juggling multiple tasks
Maintain broad knowledge of principles and best practices in molecular biology, clinical laboratories, biochemistry, and instrument functionality
Minimum 7 years of relevant experience for Senior level consideration
Experience in assay, consumable, instrument, and/or software integration required
Preferred
Experience with vendor evaluation and qualification a plus
Experience with Manufacturing process development, process transfer, process optimization, and process characterization a plus
Experience in techniques for development of IVD products under an FDA regulated environment desired
IVD / Diagnostics experience preferred
Experience in a complex medical device environment required and IVD/Hematology experience preferred
Experience in new product development for new assay, consumable, instrument and/or software components preferred
Company
DNA Electronics (DNAe)
DNAe is commercializing its pioneering semiconductor sequencing technology for healthcare applications where rapid point-of-need diagnostics are of critical need, including infectious disease and cancer testing and monitoring.
51-200 employees
H1B Sponsorship
DNA Electronics (DNAe) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (4)
2022 (1)
2021 (2)
Funding
Current Stage
Growth StageLeadership Team
Sam Reed
CEO / President
Recent News
Integrated Power Services
2025-12-03
Company data provided by crunchbase