Sr. Product Development Engineer

The Senior Product Development Engineer is responsible for the design and integration of the cartridge

and instrument as well as the development of test plans, procedures and methodologies to meet

performance requirements.

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

Qualifications

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.

• 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.

• Minimum 7 years of relevant experience for Senior level consideration

Experience in a complex medical device environment required and IVD/Hematology experience

preferred.

• Experience in assay, consumable, instrument, and/or software integration required. Experience in

new product development for new assay, consumable, instrument and/or software components

preferred.

Apply

If you believe you meet the above criteria and would relish playing a key role in developing a revolutionary technology, we would be delighted to hear from you.

We offer a competitive compensation package to successful candidates.

Please email your CV and cover letter to: HR-US@dnae.com quoting

Your name and the job title in the subject line.

For more information about DNAe, please visit our website www.dnae.com

DNAe is committed to offering staff a competitive remuneration package, alongside compelling benefits. As the primary part of the process, we conduct a rigorous market data review where each role is individually benchmarked using a vast amount of recent data. The estimated base salary range for the Sr. Product Development Engineer role based in Carlsbad, California is: $135,000 to $150,000. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly.

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, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), 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, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.