Careers at Optovue

Optovue Incorporated is a privately-held ophthalmic device company dedicated to working with eye care professionals and clinical researchers to lead the commercialization of new imaging modalities that improve diagnosis and therapy of ocular disease. Optovue has achieved widespread market success through a combination of unique data analysis design, a reputation for excellent customer service, and rapid innovation of its technology in response to physician feedback. The company is headquartered in Fremont, CA, with operations in Carlsbad, CA and European operations in Dossenheim, Germany.

Optovue offers excellent benefits and competitive salary for the positions listed below. To apply for a position, please email your resume to HR@optovue.com.
___________________________________________________________________________________________
Document Control Manager

This position reports to the Vice President of Regulatory Affairs and Quality Assurance and is responsible for technical documentation procedures and practices. The Document control manager ensures proper document controls and records tracking processes consistent with a regulated environment. The role may conduct assessments of complex data projects involving records management and recommend solutions. The incumbent is current on the field’s concepts, practices, and procedures. May lead or supervise the work of others.

Responsibilities:

Creates and implements quality procedures and works with cross-functional teams
Trains others on the Quality Management System and compliant change process.
Manages the document review and approval system
Tracks document change requests to ensure review and approval timelines are maintained
Publishes effective guidance documents and maintains masters as well as controlled documents.
Maintains the document control database and provides associated metrics
Provides tracking and trending of preventive and corrective actions
Generates associated metrics.
Other duties as assigned by management.

Requirements:

BS/BA degree in a scientific discipline preferred or equivalent experience
Minimum of three years of relatable experience in the medical device industry.
Experience with Windchill™ or other electronic PLM software.
Demonstrated proficiency in GDP, GMP and ISO 9001.
Good familiarity with FDA Quality Management Systems is essential.

******************************************************************************************************************
Manager/Director of Clinical Affairs

The Manager/Director of Clinical Affairs assures clinical studies are conducted in compliance with the protocol, Good Clinical Practice, and appropriate federal, state and local requirements.

Responsibilities

Review, evaluation, analysis and reporting of moderate to complex clinical data.
Negotiating and preparing legal and financial documents e.g. contracts, budget proposals, confidentiality and indemnification agreements, insurance, etc.
Primary responsibility for interactions with internal product development teams and CROs related to the planning and management of assigned clinical research projects/trials
Evaluation, selection and management of Contract Research Organizations (CROs) and other contract vendors
Maintaining up-to-date, in-depth operational knowledge of Good Clinical Practices, regulatory and industry best practices
Advising management of current key developments and their implications
Creating reports regarding clinical trial results or progress.
Providing clinical input for and possibly attending meetings with the FDA.
Responsible for the planning, writing and/or review of clinical input into regulatory submissions to FDA including IDEs, NDAs, 510(k)s, and annual reports, etc. for assigned projects
Writing or managing the writing of clinical protocols, Investigator Brochures, Clinical Study Reports and other clinical documents as required for assigned projects.
Other projects as assigned by senior management

Requirements:

Sound knowledge of the areas of focus
M.Sc., Ph.D., or M.D. degree in related fields
At least 5 years of industry/related experience, especially managing multi-center clinical trials and regulatory submissions
Demonstrated project management skills
Good oral and written communication skills

******************************************************************************************************************
Manufacturing Engineer

The Manufacturing Engineer is responsible for developing, implementing and maintaining methods, operation sequence and processes in the fabrication of parts, components, sub-assemblies, and final assemblies. Interfaces with Engineering in coordinating the release of new products. Also interfaces with the Production Floor, Quality Assurance, Service, Purchasing, Planning and Cost Accounting on a regular basis. Estimates manufacturing costs, determines time standards, and makes recommendations for tooling and process requirements of new or existing product lines. As required, maintains records and reporting systems for coordination of manufacturing operations. Interfaces with suppliers and customers to resolve technical issues. In addition:

Responsibilities:

Composes Engineering Change Orders to document all changes to production processes, tools or parts as required
Trains production personnel and evaluates their performance in following procedures and creates clear instructions for production tasks
Develops and implements production line layouts and techniques to increase productivity, reduce inventory and improve product quality
Identifies, analyzes and resolves production line problems
Determines tool, fixture and equipment needs for in-process use, sourcing or designing as required to improve the manufacturing process or product yields
Resolves issues with suppliers to ensure timely availability of quality parts
Assists quality and purchasing in supplier audits
Deep knowledge of Build of Material (BOM), Manufacturing Processing Instructions (MPI), Corrective and Preventative Actions (CAPA) and New Product Introduction (NPI) and follow-up to these and other standard processes
Performs other tasks as assigned by the Director of Operations with minimal supervision

Requirements:

Requires a BS degree in an engineering discipline or equivalent (CS, EE, IE, ME)
A minimum of 5+ years experience as a manufacturing engineer
Strong experience in designing production processes and test processes for instruments

Please email your resume to HR@optovue.com

******************************************************************************************************************
Software Engineer-gui+db

This position is an important part of a team of engineers and will provide hands on software development of database and graphic utilities for medical imaging data storage, analysis, 2D & 3D image visualization, and printing.

Responsibilities:

Responsible for implementation, integration and testing software modules.
Continue to improvement the performance for the current software.
Continue to improve the speed, memory management and database development.
Provides high level troubleshooting support to product development teams.
Planning, designing, and implementing from software requirement specifications.
Improve the current GUI to accommodate an interface with the application’s user in an intuitive and simple manner.

Requirements:

BS/MS degree in software engineering or computer science. Minimum 5 years of industrial experience in related software design.
Minimum 5 years experience in MFC, Win32 SDK, Database programming in MS SQL Server and/or Boland Interbase.
Experience in design, create , and maintain databases, stored procedures, performance tuning, custom queries.
Must have at least 3 years complex GUI design experience. Strong Model-View-Control GUI development. Working experience with data compression is a plus.
Strong programming skills, experience with Object-Oriented Programming and Design (OOP/OOD) and design patterns.
Familiar with SQL, XML, MFC, Windows software and database development with practical experience in modern programming languages (C++, Visual Studio, MFC) and common database (SQL server) technologies.
Demonstrate strong skill in memory management, multi-thread and client/server networking programming experience.
Understanding of the Software Development Lifecycle, Object-Oriented/AOP architectures and development principles and practices.
Good communication and documentation skills are essential.
Ability to work independently and as part of a team, ability to solve complex problems and multitask.
Ability to learn new applications and processes quickly are also necessary for this position.
Comfortable and adaptable working in a dynamic, high-paced environment. Self- motivated, excellent attention to detail, and ability to deliver under tight schedule.
Demonstrated success in system or software design and development in a small team environment.
Knowledge of medical imaging such as X-ray, Ultrasound, MRI, optical image, EMR, and DICOM standard are highly desired.

******************************************************************************************************************
Software Engineer-gui+3D

Responsibilities:

Responsible for implementation, integration and testing software modules.
Continue to improvement the performance for the current software.
Continue to improve the functionality, memory management and performance of 2D and 3D image processing and display in current software.
Provides high level troubleshooting support to product development teams.
Planning, designing, and implementing from software requirement specifications.
Improve the current GUI to accommodate an interface with the application’s user in an intuitive and simple manner.

Requirements:

BS/MS degree in software engineering or computer science. Minimum 5 years of industrial experience in related software design.
Minimum 5 years experience in MFC, Win32 SDK.
Must have at least 3 years 2D and/or 3D presentation programming experience. Working experience with VTK, OpenGL, CUDA, OpenCL or DirectShow is a plus.
Must have at least 2 years complex GUI design experience. Strong Model-View-Control GUI development. Working experience with data compression, and real-time video data streaming is a plus.
Strong programming skills, experience with Object-Oriented Programming and Design (OOP/OOD) and design patterns.
Demonstrate strong skill in memory management, multi-thread and client/server networking programming experience.
Understanding of the Software Development Lifecycle, Object-Oriented/AOP architectures and development principles and practices.
Good communication and documentation skills are essential.
Ability to work independently and as part of a team, ability to solve complex problems and multitask.
Ability to learn new applications and processes quickly are also necessary for this position.
Comfortable and adaptable working in a dynamic, high-paced environment. Self- motivated, excellent attention to detail, and ability to deliver under tight schedule.
Demonstrated success in system or software design and development in a small team environment.
Knowledge of medical imaging such as X-ray, Ultrasound, MRI, optical image, EMR and DICOM standard are highly desired.

******************************************************************************************************************