Engineer II

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, we are seeking an Engineer II to join our R&D Field Triage group. This individual will assist in conducting technically challenging investigations to address on-market product quality issues and recommend solutions.

This role involves working in a highly collaborative team setting to provide R&D investigational support including design, execution and documentation of experiments to systematically identify failure mode / s and establish root cause / s with clinical laboratory and transfusion medicine products.

This position is on-site at our Rochester, NY facility.

Responsibilities

Assess failure modes of potential quality issues of a systems nature related to hardware / software, reagents, samples, testing protocol and consumables reported by customers and internal stakeholders.

Critically examine the interface between hardware and software designs and the performance of on-market chemistry products.

Learn the operating principles of complex electro / mechanical / software systems and scientific principles of how assays work.

Conceptualize system design changes to correct product quality issues.

Collaborate with cross-functional representatives in quality, customer support, lifecycle management team, operations and our development partners, to define product issues and deviation from intended performance.

Analyze data from instruments in worldwide AWS databases. Use knowledge of data analytics and statistics to discern significant trends to assess contribution of potential root causes.

Assist in designing and conducting laboratory studies to determine root cause of product quality issues for clinical chemistry, immunoassay, and immunohematology applications.

Document and maintain investigation records and findings as part of an auditable Quality System.

Present investigative findings to the investigation team and department manager in a way that enables broad dissemination and actionable use of technical knowledge.

Conduct hands-on work activities in a biosafety level 2 laboratory, which includes modifying and adjusting complex analyzer systems along with competent use of lab equipment such as pipettes, balances, analytical instruments and QuidelOrtho end-user equipment.

Maintain accurate records of work performed in accordance with Current Good Laboratory Process (cGLP) practices, established quality protocols and other standard operating procedures (SOPs).

Maintain a safe working environment through the proactive identification of hazards and risks.

Work cooperatively with others to ensure efficient, timely and quality project outcomes.

Perform other work-related duties as assigned

Individual

Required :

Minimum of a BSc in Engineering or related scientific discipline. Biomedical, Chemical, Mechanical, or Systems Engineering preferred.

Minimum of 1-3 years progressive work experience.

Systems thinking acuity and a keen interest in diving deep into complex product issues and learning different technologies.

Experience with experimental write-ups and English fluency.

Basic computer skills (MS Word, Excel, PowerPoint, Outlook etc.).

Preferred :

Experience with clinical chemistry and / or immunohematology systems.

Curiosity to deep dive into the details of complex hardware and software systems and discover unanticipated interactions.

Experience in experimental design and results analysis, including data evaluation and interpretation.

Demonstrated ability in technical analysis and evaluation of data, including good understanding of basic statistics.

Experience with statistical software.

Experience with SQL, MATLAB and other programming / scripting languages.

Experience with Six Sigma, Kepner-Tregoe or other problem solving methodologies.

Ability to carry out general biochemical laboratory procedures including handling of human samples and reagents for testing purposes.

Excellent organizational skills.

Excellent communication, influencing and conflict resolution skills.

Flexibility and adaptability; ability to prioritize within a changing business environment.

Customer-oriented mindset to better anticipate needs, resolve issues quickly and ultimately create a better user experience.

Good judgment working independently and within a team setting.

Key Interactions

Internal :

R&D Field Triage Team (of which this job is part), Systems R&D Team (for collaborating on investigations), Development Teams (for translating proposed solutions into actual designs), Quality (for compliance process), Operations (for deep subject matter expertise of manufacturing processes), Global Service Organization (for seeking additional information, and for communicating findings).

External :

Development Partners and Suppliers (for deep investigational and raw materials assistance, and for translating proposed solutions into CAPA), Customers (for additional information related to investigations).

Work Environment

The work environment characteristics are representative of an office, laboratory and manufacturing environment and include handling of biological samples, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Flexible work hours to meet project deadlines.

Physical Demands

This position requires the ability to work in a biohazard lab environment and requires use of protective equipment (safety glasses, gloves, lab coats). The position requires the ability to sit, stand, walk, bend, squat, push and pull, repetitive movement (pipetting of samples). Up to 50% working in the lab, standing or sitting extended periods of time.

Salary Transparency

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 that facts and circumstances of each case. Salary range for this position is $68,000 to $95,000 and is bonus eligible. 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 Employment 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 their 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 recruiting@quidelortho.com .

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