Sr. Product Development Engineer

The Senior Product Development Engineer (one-year contract role) 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.

• 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 is a plus.
• Other duties as assigned.

• 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 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 is a plus.
• Experience with manufacturing process development, process transfer, process optimization, and process characterization is a plus.
• Experience in techniques for development of IVD products under an FDA‑regulated environment.
• Minimum seven years of relevant experience for senior‑level consideration.
• Experience in a complex medical device environment is required, and IVD/Hematology experience is preferred.
• Experience in assay, consumable, instrument, and/or software integration is required. Experience in new product development for new assay, consumable, instrument, and/or software components is preferred.

• Seniority level:
  Mid‑Senior level
• Employment type:
  
  Contract
• Job function:
  Engineering and Information Technology
• Location:
  
  Carlsbad, California

The estimated base salary range for this role is $135,000 to $150,000. Compensation decisions are dependent on several factors including qualifications, location, internal equity, and market data.

DNAe, Inc. is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. The company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment and will comply with all applicable federal, state, and local laws concerning employment discrimination.

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.

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For more information about DNAe, please visit our website .