POSITION: NPD and Sustaining Engineer
JOB LOCATION: Irvine, CA
CLASSIFICATION: Exempt
STATUS: Full Time
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 New Product Development and Sustaining Engineering (NPD&SE) transitions new medical device designs from the feasibility stage of research into full scale production and supports all engineering aspects of maintaining existing products. The NPD&SE will work closely with the Regulatory Affairs and Quality Assurance Department to compile and maintain documentation in the Technical File for each product as required by FDA and other regulatory agencies.
ESSENTIAL FUNCTIONS OF POSITION
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- Work closely with the Chief Technical Officer and the Head of Research to establish manufacturing feasibility for new product development.
- Provide Design for Manufacturing inputs to help develop Product Specifications (P-Spec), including materials and methods of production.
- Work closely with the Director of Regulatory Affairs and Quality Assurance (RA/QA) and the VP of Operations to create Product Development Plans for new products.
- Serve as Technical Project Manager, managing all 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).
- Create and maintain engineering drawings, CAD/CAM models and work/assembly instructions.
- Develop process validation plans to establish documented evidence of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new or modified production activities.
- Trouble shoot production and product reliability issues by analyzing statistical data for returned goods (RGAs), manufacturing nonconformities (NMR) and customer feedback to develop opportunities for product improvements.
- Initiate and manage Engineering Change Requests (ECR) and identify, assess, and mitigate associated risks.
- Identify and develop mitigation plans for product risks associated with methods or materials material production
- Work with the Director of RA/QA to maintain and improve the QMS Standard Operating Procedures (SOPs) for new product realization, change management, and manufacturing processes.
- Support Quality and Regulatory Audits
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DESIRED SKILLS AND EXPERIENCE
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- Eight to ten years of experience in the medical device industry.
- Exceptional Mechanical Aptitude (Opto-mechanical experience preferred)
- Strong computer skills including CAD experience (OnShape, SolidWorks, etc.)
- Demonstrated written and verbal communication skills
- Demonstrated independent worker with ability to focus
- Demonstrated attention to detail
- Able to collaborate well with others.
- Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803, MDSAP and ISO 13485 standards under the MDR.
- Experience in Root Cause Analysis for Corrective and Preventative Action (CAPA) Processes.
- Familiarity with medical device complaint files and quality records
- Experience in IEC 60601-1 Basic Safety coordinating product testing for General Safety and Performance Requirements (SPRs)/Essential Elements.
- Experience with Software Lifecycle Management per IEC 62304 for Class 2 FDA products.
- Experience in Risk Management Engineering for medical products per ISO 14971.
- Experience in Usability Engineering per IEC 62366
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WORK LOCATION
This NPD and Sustaining 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 NPD and Sustaining 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.
