Sr. System Development and Integration Engineer, Diagnostics (#0074) Singulex

Category: Diagnostics
Summary

Description

Execute system-level test plans for use in conjunction with the Singulex ErennaTM System Immunoassay platform. This is a high-visibility, hands-on bench level laboratory position.
May be required to work non-standard hours; for example, second shift, some weekends.
Under minimal guidance of senior personnel designs and conducts product development, assay integration and scale-up tasks and experiments based on the needs of the group effort. May also be involved in planning and execution of experiments that support feasibility investigations for newly proposed projects.
Generate, document, and review studies related to the Verification and Validation of the System 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. May work on independent projects.
Presents data at Team meetings or to small focus groups that may include representatives from other departments and/or outside parties. Participates in and may lead brainstorming and troubleshooting sessions.
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.
Tasks will include system feasibility studies, liquid handling optimization, assessment of consumables, and performance studies to meet product specifications.
Occasional 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 4-6 years relevant work experience with basic knowledge of system development principles, concepts, and theories. 2+ (PhD), 4+MS degree acceptable.
Industry experience in a regulated environment (In-Vitro Diagnostic (IVD) and immunoassay development experience preferred).
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 requirements for In-Vitro Diagnostic products 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.
Experience in providing training to laboratory staff on new equipment and processes.
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.
Basic knowledge of optics, and ability to optically align an instrument following a procedure highly desirable.
Excellent cross-functional team leadership and participation skills.
Highly organized and detail-oriented.
Results and goals oriented.
Excellent written and oral communications.
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.
Having integrity and a strong work ethic.
Passionate for both personal and corporate success.
Ability to work independently with minimal supervision and as a member of a team.
Commitment to quality.
Enthusiasm, attention to detail, the ability to meet aggressive deadlines, ability to think out of the box, and ability to work effectively with others in a fast paced, highly-productive environment.

Location:	3507 Breakwater Ave Hayward, CA 94545 United States