Engineering – Sr. Hardware Design Engineer – Irvine, CA

Irvine, CA (Onsite)           ·         Full Time

Position: Engineering – Sr. Hardware Design Engineer 
Job Location:  Irvine, CA
Classification:  Exempt
Status: Full time Salaried
Department: Engineering

About NeurOptics

NeurOptics provides pupillometry products to hospitals and clinicians worldwide and is the leader in the science of pupillometry. Driven by a passion to help clinicians provide improved patient outcomes, the company has developed innovative technology for use in the areas of critical care nursing, critical care medicine, neurology, neurosurgery and emergency medicine which enables clinicians to enhance their patient evaluations by providing information from the human eye to facilitate critical medical decision making. Headquartered in Irvine, California, NeurOptics conducts business in North America, Europe and Asia.

At NeurOptics, we are passionate patient advocates. For us, helping clinicians provide improved patient outcomes is our life’s work.

Job Summary

The Sr. Hardware Design Engineer is responsible for all aspects of hardware development within an embedded systems environment. General responsibilities range from conceptual design, detailed design (a combination of analog, digital, embedded firmware, schematic capture, board layout), analysis, overseeing fabrication of hardware, defining, and executing qualification/testing plans as well as project management.

Essential Functions Of Position

• Work closely with the Chief Technical Officer and the Head of Research to design, develop and test new embedded hardware.
• Support and enhance existing embedded hardware.
• Generate complete and accurate design documentation.
• Provide input to architecture and design reviews.
• Keep current with embedded hardware trends and share knowledge.
• Perform or assist in design verification of products.
• Work closely with the Director of Regulatory Affairs and Quality Assurance (RA/QA) and the Engineering Project Manager to create Product Development Plans for new products.
• Serve as a Technical Project Manager, managing all hardware engineering aspects of new product development from the point of proof of technical feasibility into full production, under design control utilizing Neuroptics’ Quality Management System (QMS).
• Support Quality and Regulatory Audits
• Bring a Self-Starter, Highly Motivated Attitude to the role.

Desired Skills And Experience

• Bachelor’s Degree in Electrical or Computer Engineering or equivalent.
• 5 yrs. + Board level development experience utilizing high-speed digital circuits is required.
• 5 yrs. + Support of full life cycle of embedded system design from specification, development, design verification/validation testing, transition to production sustaining engineering product support.
• Experience with IMX. 6 processors, pic microcontrollers, wireless Wi-Fi and Bluetooth highly desired.
• Trouble shooting when needed required.
• Demonstrated written and verbal communication skills.
• Demonstrated independent worker with ability to focus.
• Demonstrated attention to detail.
• Able to collaborate well with others.
• Medical device industry experience preferred.
• Knowledge of FDA regulations, 21 CFR part 820 and Part 803, MDSAP and ISO 13485 standards under the MDD/MDR a plus.
• Experience in Root Cause Analysis for Corrective and Preventative Action (CAPA) Processes.
• Knowledge of IEC 60601-1 Basic Safety product testing for General Safety and Performance Requirements (SPRs)/Essential Elements preferred.

Work Location

This Sr. Hardware Design Engineer will work from our Headquarters in Irvine and is not a remote position.

Benefits

NeurOptics is very proud to offer its employees a competitive employee benefits package which includes a 401K, healthcare insurance program and paid vacation.

Physical Requirements And Work Environment

The Sr. Hardware Design Engineer position is 100% office-based, located at our Company Headquarters in Irvine. This position requires sitting for extended periods when facilitating our order-entry processes. Daily meetings with various internal departments require frequent movement across two company floors. Daily use of a computer and other computing and digital devices is required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The Company will provide reasonable accommodations to permit individuals with qualified disabilities to perform the essential functions of the position as may be required by law.

To apply, please submit a resume and cover letter to: Careers@NeurOptics.com

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