- 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.
- 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 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.
- Instrument V&V Theory & Application.
- ISO 13485, ISO / EN ISO 14971 and FDA QSR experience.
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Instrument Verification and Validation Engineer - San Diego, United States - Ortho Clinical Diagnostics
Description
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
As we continue to grow as QuidelOrtho, we are seeking a 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.
The Responsibilities
The Individual
Required:
Preferred:
The Key Working Relationships
Project Managers and R&D Directors to address problems, identify solutions, resolve timelines issues, and communicate conflicting project goals. Contract product development teams to ensure products meet Quidel requirements and quality standards and are documented in accordance with ISO and FDA requirements. Provides updates to Management and to Project Teams, when participating in cross-functional teams. Ensures all issues related to the success of the product launch are communicated to the Manager Quality Assurance.
The Work Environment
The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues, and samples. Position requires ability to lift to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted. Occasional travel required. Travel includes airplane, automobile travel and overnight hotel.
Salary Transparency
The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $78,600 to $134,000.
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. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
Equal Opportunity
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at .
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