Staff Product Line Engineer

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

The Staff Product Line Engineer position is responsible for selecting the processes to be used, determine the order of operation, and ensuring that all special equipment required to manufacture Quidel products are available for use.  Individuals will provide direction and support to Manufacturing to ensure that production processes are robust.  Key activities include, but are not limited to,   control/mitigation of process drift, leading troubleshooting investigations, conducting Corrective and Preventative Actions, implementing process improvements, assessing feasibility of new manufacturing technology, revising/ creating new documentation for Manufacturing (manufacturing instructions, routings, bills of material, SOPs, etc), validation of new or improved manufacturing processes, and integrating new products and analytical methods from R&D into Operations.

This position will be located onsite in  San Diego, CA.

The Responsibilities

• Characterize, optimize, validate and ECO manufacturing processes to improve efficiency and robustness of current processes.

• Represent Product Line Engineering in assigned R&D and Project Team meetings for technology transfers, and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing.

• Leads RCAs and RCCMs for core manufacturing team.

• Executes all tasks in accordance with Quidel’s Quality System and carries out duties in compliance with established business policies.

The Individual

Required:

• BA/BS in life sciences or engineering and 8+ years’ experience within a cGMP manufacturing environment.

• Strong analytical and problem-solving skills

• Good knowledge of process optimization, scale up and standardization.

• Good organizational skills, and the ability to manage multiple tasks

• Ability to plan and execute experiments.

• Develop new processes and set specifications

• Characterize materials and set specifications

• Troubleshoot problems

• Write and execute associated validations

• Ability to work within cross-functional teams.

• Strong communication skills, written and verbal.

• Strong knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.).

• Demonstrates ability to consistently meet proposed timelines, applying competent use of project planning and project management skills

• Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts)

• Knowledge of related quality system regulations and processes

• Appropriate computer skills (e-mail, word processing, graphing software)

Preferred:

• Experience in lateral flow technology

• Analytical Method Development

The Key Working Relationships

Internal: Manufacturing, Engineering, Quality, R&D, and Regulatory

External: External contractors and vendors.

The Work Environment

The work environment characteristics are representative of an office, laboratory, and manufacturing environment. Core work hours with occasional flexibility to meet project deadlines and support of manufacturing goals. Position requires ability to flexibly spend time sitting and standing working at a desk, collaborating in meetings, and hands-on product testing in a laboratory or manufacturing environment.

The Physical Demands

Position requires ability to lift up to 20 lbs. on occasion.  Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time 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. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

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 $108,000 to $183,000. 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 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.