Instrument Verification and Validation Engineer

QuidelOrtho • San Diego, CA

2d • $85,000 - $95,000 • Onsite

About The Position

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Instrument Verification and Validation Engineer to support our Instrument Systems team. This role provides Instrument Verification and Validation (V & V) support for new products, assay / instrumentation integration, technology transfer and other instrument V & V activities. Integrates engineering theory and practice within the areas of new product development, manufacturing, and marketing support. This position will be onsite full-time working out of San Diego, CA – Summers Ridge, HQ. Note: This position is not currently eligible for visa sponsorship.

Requirements

• Bachelor’s or master’s degree in computer science, Mechanical Engineering, Electrical Engineering, System Engineering or any other related fields required.
• From 1 to 5 years of experience required, preferably in a pharmaceutical or medical device environment.
• An understanding of IEC 62304 (Medical Device Software – Lifecycle process) or equivalent FDA software development requirements.
• Good analytical and problem-solving skills.
• Good organizational skills, and the ability to manage multiple tasks.
• Experience in product development and experimental design.
• Ability to work within cross functional teams.
• Strong communication skills, written and verbal.
• Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation.
• Working knowledge of relevant analytical tools.
• Ability to participate in planning and managing projects.
• Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management).
• Knowledge of related quality systems regulations and processes.
• Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software).
• Must have some knowledge of basic Programing, Scripting, setting up an Automation Environment and Test Automation development.
• Knowledge of Application life cycle management (Agile method preferred).
• Know and understand the software test cycle.
• Ability to write test plans, test cases and test reports.
• Ability to travel up to 5%

Nice To Haves

• Instrument V&V Theory & Application.
• ISO 13485, ISO / EN ISO 14971 and FDA QSR experience.

Responsibilities

• Participates on design teams, understands project goals and timelines, and provides support to ensure product launch success.
• Communicates project status, challenges, and concerns to area management pro-actively.
• Writes instrument design control documentation and executes associated test and risk management activities.
• Works with R&D on instrument V & V approaches to develop, automate, optimize, and integrate diagnostic assays with instrumentation.
• Maintains project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process.
• Supports the Instrument Systems product vision on project teams.
• Provides instrument software provision in the development and implementation of functional strategies to support corporate goals and objectives.
• Carries out duties in compliance with established business policies.
• Test Automation setup and development.
• Perform other work-related duties as assigned.

Benefits

• QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level