System Engineer

Role: Systems Engineer with Electrical focus

Location: 25155 Rye Canyon Loop, Valencia, CA 91355

Duration: 12 Months Contract

Job Description:

• Develop new manufacturing/test equipment and software used in the development and production of medical devices. Independently or as a member of a team directs, develops, concepts, and executes specifications, designs, plans and builds of complex manufacturing and test equipment.

Key Responsibilities:

• Leads or participates on project teams to develop clear specifications, evaluates feasibility of concepts, and provides formal estimates for electrical/software designs.
• Coordinates, monitors, and documents project designs, estimates, and costs.
• Creates electrical/software designs utilizing the departments’ standard development tools and procedures.
• Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements.
• Prepares standard reports/documentation to communicate status and results
• Leads project teams that include Designers, Engineers and Technicians in the design, assembly, and debug of equipment.
• Designs electrical systems and specifies electrical components.
• Identifies pneumatic components and automated control requirements.
• Completes FDA/QSR equipment requirements by assisting in the creation of specifications and qualifications.
• Provides training as required to ensure that the controls systems can be operated effectively.
• Provides leadership role on championing functional best practices.
• Influences and defines functional, departmental and divisional procedures through involvement with cross-functional engineering initiatives.

Quality Systems Duties and Responsibilities:

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications:

• Minimum 5 Years experience per below, with BS, 3 - 5 Years with MS
• 5 - 7 Years with BS, 3 - 5 Years with MS

Must have:

• Python experience
• Electronic hardware design experience
• Hardware-software integration experience
• Test infrastructure verification and validation experience
• Experience bridging high-level system architecture with detailed electronic hardware design
• Analytical mindset
• Excellent statistical analysis
• Risk & Safety optimization experience
• Excellent collaboration and communications
• Medical device experience highly preferred
• Former regulated environment required