QuidelOrtho Hiring for Director, Software Engineering at San Diego, CA  Full Time

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 grow as QuidelOrtho, we are seeking a Director, Software Engineering. This role will drive development, release and lifecycle of digital product and informatics solutions for off and on-premises opportunities.

As a Director, Software Engineering, you will be the primary technical and team leader for our digital product portfolio, partnering with our business and technical teams to identify, build, launch and scale our solutions. You will architect and deliver a portfolio of exceptional applications and platforms that support and differentiate our businesses.

This role sits within our Digital Innovation team, which identifies and builds our clinical and diagnostic digital solutions. You will join a dynamic and high-growth environment empowered to transform the organization, take informed risks, and drive innovation across our markets.

This position will be remote eligible. If you are local to San Diego, CA, Raritan, NJ or Rochester, NY – you will have an opportunity to come into the office when needed.

The Responsibilities

• Leads overall technical and development efforts for software product applications and platforms.
• Drives key architecture, technology, and partnership decisions.
• Manages and leads software development teams including hiring, training, coaching, and mentoring.
• Plans and drives department activities including requirements, design, development, test and delivery.
• Works with Business Unit, R&D and IT to evaluate opportunities, develop roadmaps, and launch consistently on time.
• Provide requirements to instrumentation teams enabling data assets that power your platforms and solutions.
• Drive technical oversight with the team, including DevOps, testing, and quality assurance practices.
• Directs long and short-term planning for the department including headcount, budgeting, training, and systems requirements.
• Teams up with QA/RA for regulatory submissions and correspondences with Legal Authorities (eg FDA).
• Collaborates with Legal to strengthen our IP Portfolio and secures Freedom to Operate for our initiatives.
• Ensures department adherence to policies, including privacy, security, data standards, and all other legal and regulatory directives.

The Individual

Required:

• Bachelor’s degree required, ideally in computer science or computer engineering.
• 8+ years of software development experience.
• Strong people management skills, with proven success in motivating high performing project teams.
• Communication skills including success in presenting to senior leaders and non-technical stakeholders.
• Deep knowledge of software engineering, both process and tools (incl. continuous integration and testing).
• Proficient with regulated software development lifecycle (SDLC) methodologies.
• Excellent knowledge of IEC 62304 and IEC 82304-1 environments.
• Excellent knowledge of application of ISO 14971 to medical device software.
• Travel: Ability to travel 20%

Preferred:

• 3+ years managing on-site and remote teams.
• Deep experience in Class II/III SaMD or regulated software including FDA approval or CE marking.
• Experience with medical software best practices: validation, documentation, risk assessment, security, and health data.
• Working knowledge of ISO 13485.
• Experience in one or more of the following areas:
  • Standards for Cybersecurity – IEC 62443 series, FDA guidance.
  • General Data Protection Regulation (EU) 2016/679
  • Interoperability standards such as HL7 V2.5 and FHIR
  • Healthcare data standards such as LOINC and SNOMED

The Key Working Relationships

Internal Partners:

• This person will work cross functionally with Product Management, R&D, IT, Global Marketing, Customer Support Services, Finance and Human Resources.

External Partners:

• Third party vendors and/or customers.

The Work Environment

Typical office environment. Travel for team or customer visits, up to 20% per month or 4 travel days. No strenuous physical activity, though occasional light lifting of files and related materials (up to 10 lbs.) is required. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, regularly required to use hands to finger, handle, or feel and talk or hear. Frequently required to stand, walk, and sit. Occasionally required to reach, climb, or balance. On a typical day, 80% of time is spent at the desk, on the phone, or working at the computer; 20% in meetings or interacting with team members. May require significant domestic or international travel.

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 that facts and circumstances of each case. The salary range for this position is $135,700 to $250,000 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 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 [email protected]

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Equal employment opportunities for all employees. We fulfills this commitment through a variety of measures including internal & external posting of job openings, hiring, training & promoting individuals without regard to race, color, religion, sex, pregnancy, national origin, ancestry, citizenship, veteran status, disability, medical condition, marital or domestic partner status, sexual orientation, gender identity, age,or any other considerations made unlawful by federal,state or local law