Job Details

About the Role

The Senior Product Development Engineer is responsible for the design and integration of the cartridge and instrument, and for developing test plans, procedures, and methodologies to meet performance requirements.

Responsibilities

• Successfully integrate assay, cartridge (consumable), instrument, and software components to support development, transfer, verification/validation, and commercialization of new products.
• Collaborate with Core Team representatives from various departments to determine design inputs, translate them into specifications and design outputs, optimize the design to meet performance requirements, 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 the plans and generate reports.
• Lead the team in generating test procedures, executing test protocols, and producing test reports.
• Develop and optimize assay profiles using system and/or lab development software, and fine‑tune 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 performance.
• Demonstrate the ability to follow protocols and workflow instructions.
• Work knowledge of regulatory and safety standards (a plus).
• Other duties as assigned.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or a closely related discipline.
• Strong presentation and influencing skills, and outstanding verbal, written, and documentation skills.
• Excellent collaboration and interpersonal skills to work well with scientists and engineers from diverse backgrounds.
• Strong organizational skills and the ability to manage work for multiple people.
• Comfortable working in a fast‑paced, dynamic environment while juggling multiple tasks.
• Broad knowledge of principles and best practices in molecular biology, clinical laboratories, biochemistry, and instrument functionality.
• 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 developing IVD products under an FDA‑regulated environment.
• Minimum 7 years of relevant experience for Senior level consideration.
• Experience in a complex medical device environment (required); IVD/Hematology experience (preferred).
• Experience in assay, consumable, instrument, and/or software integration (required); new product development for these components (preferred).

Compensation and Location

The estimated base salary range for this role based in Carlsbad, California is: $125,000 to $140,000.

How to Apply

Please email your CV and cover letter to: ...@dnae.com, quoting your name and the job title in the subject line.

Equal Employment Opportunity

DNAe, Inc. is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including recruitment, interviewing, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs.