Principal Systems Engineer Job

PRINCIPAL SYSTEMS ENGINEER needed for a contract opportunity with Yoh's client located in Thousand Oaks, CA.

THE BIG PICTURE:

- Create and update requirement traceability that ties the related sub-systems.
- Develop system architecture and design documents.
- Coordinate system level engineering testing, system engineering processes, procedures and guidelines to the latest industry standards.

WHAT YOU'LL BE DOING:

- Successful candidate will participate in the development of drug delivery systems with a focus on the delivery device and interfaces to different system components including system software.
- Scope will include wide range of devices including needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, micro-infuser delivery pump systems and drug delivery decision support systems.
- The Principal Systems Engineer will work closely with members of the Product Development organization to translate high level requirements into engineering specifications, and system interface specifications which in turn support the design, development, validation, regulatory submission of these systems.
- The role of the Principal Systems Engineer is to work within a cross-functional organization to define, integrate and deliver the drug delivery system.
- Create system specifications, interface control/design documents, device specifications, software architecture.
- Coordinate between various groups to ensure the system meets all requirements.
- Lead and oversee system and subsystem hardware and software integration and acceptance testing.
- Generate, maintain, and track system deliverable schedules.
- Interface with internal cross-functional teams and contract manufacturers or design partners to ensure system design, architecture, and verification/validation meets design input.

WHAT YOU NEED TO BRING TO THE TABLE:

- Doctorate degree and two (2) years of directly related experience OR
- Master's degree and six (6) years of directly related experience OR
- Bachelor's degree and eight (8) years of directly related experience OR
- Associate's degree and ten (10) years of directly related experience OR
- High school diploma/GED and twelve (12) years of directly related experience

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- BS in Engineering or computer science and previous experience in a medical device industry
- 10 years current experience with system engineering processes and procedures.
- Led projects from development through the 510k and PMA approval process.
- Broad understanding of systems and software engineering methodologies.
- Experience with DOORS, Requisite Pro, or similar requirements management software.
- Experience with software development life cycle and software defect management processes and tools.
- Familiar with the following standards:
- US Good Manufacturing Practices - 21CFR820
- Quality Management - ISO 13485 Needle-based injection systems ISO 11608
- Medical Electrical Equipment - EN 60601 o Risk Management - ISO 14971
- Ability to read, analyze, and interpret technical standards, procedures, or governmental regulations.
- Ability to think and perform technically at both high and detailed levels.
- Must have strong oral and written communication skills and strong technical decision making skills.
- Strong problem solving, risk assessment, and risk management skills.
- Ability to converse technically with mechanical, electronic, software, and quality engineers.
- Must be capable of working on multiple projects in a deadline driven environment.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kathy Pavlick

Yoh, a DayJ2W: ENG

Tax Term: CON_W2J2WBRSDIEGO

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SFSF: ENG