Design Control Specialist, Intermediate
Job Description
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com
Job Function
This position is in Agilent’s Companion Diagnostics (CDx) division and supports development of precision medicine diagnostic devices for oncology therapies. The Design Control Specialist will work closely and collaboratively with specialists in R&D, project management, clinical affairs, regulatory affairs, manufacturing and quality assurance teams to guide the development of high-quality companion diagnostic products by planning and executing design control processes and strategies as part of our Quality Management System. Innovative ideas and excellent performance will bring value for Agilent and contribute to treating cancer. Often entails problem solving the best way to document design controls for new projects with unique challenges.
a) Organizational
Position has no reporting employees and reports to one direct manager.
b) Span of Control and Authority
Position requires the authority to draft documents, initiate workflows in Agile, and make changes necessary to support product development within the CDx R&D department.
c) Communication / Contacts
Internal: Communicate with project managers, scientists, research associates within R&D and representatives from other departments (e.g. production, RA, QA, etc.) as required to aid in development of various CDx products.
External: No planned communication with external contacts (i.e. vendors, customers, etc.); however, communication with representatives from these groups may occur. For example, employee may be required to interacts with auditors performing facility and process inspections, or to present a brief update to a pharma partner in a Joint Project Team meeting.
Job Responsibilities
Ensuring the successful design and development of new products through collaboration with cross-functional teams
Supporting development of design control records including design and development planning, risk management files, Verification & Validation (V&V) plans, requirement traceability matrices, etc.
Maintaining Design & Development File (DDF) and ensuring its accuracy
Coordinating and leading design review meetings and design changes
Contributing to and maintaining the risk management file with input from development teams
Identifying and implementing process improvements to establish standardized best practices
Working across Agilent divisions to draft and provide input to Agilent global documentation and processes
Supporting and contributing to internal and external audits
Working on problems of diverse scope, ensuring alignment and consistency wherever possible
Exercising judgment within generally defined practices and policies to problem-solve when faced with complex challenges
This can be a remote position- it does require on-site presence for certain tasks
Qualifications
1. Education
Bachelor’s degree (BS) or advanced degree in biological sciences
2. Experience
Minimum 3+ years relevant experience (product development/assay development/IHC/ISH)
Required Skills:
Strong writing skills
High attention to detail
Presentation skills (internal and external)
Excellent communication and teamwork
Ability to work independently
Preferred:
Understanding of design control regulations and documentation requirements
Knowledge in:
Immunohistochemistry
In situ hybridization
Cell biology
Molecular biology
Experience in the diagnostics industry
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1-262-754-5030 email [email protected]. EOE AA M/F/Vet/Disability/Sexual Orientation/Gender Identity.
For more information about equal employment opportunity protections, please see all of our notices for EEO below.
Additional Details
This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least May 28, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $69,120.00 - $129,600.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.
