Senior System Development and Automation Engineer Singulex -
Alameda, CA
Lead a team of development and integration personnel, to develop, support and provide continuous improvement opportunities for he Clinical Laboratory.
Execute automation development plans for use in conjunction with the Singulex Erenna® System Immunoassay platform. This is a high-visibility, hands-on bench level laboratory position.
Work close with Assay Development group and CLIA staff to transition processes and assay into production.
Ability to mentor and lead sub-teams in a multidisciplinary group.
Development and verification of system level error handling concepts.
Generate, document, and review studies related to the verification and validation of the process under development.
Critically analyzes, summarizes and reports data generated from experiments, draws conclusions from experimental results, recommends and executes follow-up actions with consideration of prior experimental findings (self and others) with minimal supervision. Proposes new investigations based on experimental findings.
Presents data at team meetings or to small focus groups that may include representatives from other departments and/or outside parties.
Ensures compliance with and helps to implement the requirements of working in a regulated environment to assure adherence to various requirements including design control, good laboratory practices (GLP), and good manufacturing practices (GMP). Follows the Singulex design control process for product development, and documents all work as required by this process. As part of a team effort is involved in the planning, and performs and documents verification activities to ensure that newly developed products meet the pre-determined product specifications and all applicable requirements of the Food and Drug Administration (FDA), QSR, ISO, and CE mark. May generate, document and review studies related to verification, validation, and transfer of developed products.
Facilitates the transfer of product development processes to manufacturing, including involvement in the completion and release of enabling documentation for newly developed products by ensuring all relevant technical information is incorporated into the appropriate documents.
May be required to work non-standard hours; for example, second shift, some weekends.
Problem solving and adjustment of the instrument mechanical and optical components, as well as work with R&D prototype instruments.
Qualifications
BS/BA degree in engineering or related field required, with 6-8 years relevant work experience with knowledge of system development principles, concepts, and theories. 4+ (PhD), 6+MS degree acceptable.
Industry experience in a regulated environment (Clinical Laboratory and immunoassay development experience preferred).
Experience in integrating and fully automating assays (i.e TECAN Evo or Hamilton) required.
Knowledge of statistics, design of experimentation (DOE), and risk analysis (FMEA, cause and effect, fishbone diagram, etc.).
Strong understanding of GLP, QSR, and ISO regulatory required.
Experience in developing and executing test plans for software, hardware and overall system integration activities.
Experience in configuration management, reliability tracking processes, software (ad-hoc) testing, and ability to compile clear and complete root cause analysis documentation.
Excellent written and verbal communication skills, as well as ability to understand, prepare, and communicate technical scientific information to a wide range of audiences.
Knowledge of immunoassay methods used for protein analysis, with experience in at least one of the following assay formats highly desirable: ELISA, bead (e.g., Luminex platform), or ECL.
Excellent cross-functional team participation skills.
Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike.
Highly organized and detail-oriented.
Results and goals oriented.
Excellent written and oral communication.
Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities.
Ability to inculcate the Singulex Top-5 core values and serve as positive example to team members and others within the organization.
Effective personal communication skills, shares knowledge with excellent training skills.
Having integrity and a strong work ethic.
Passionate for both personal and corporate success.
Ability to work with minimal supervision as a member of a team.
