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 Description:

 We are seeking a highly motivated and detail-oriented scientist for Design Control Documentation. The successful candidate will focus on the design control documentation of medical devices for diagnostic use within the fields of tissue-based pathology assays such as immunohistochemistry.

Key Responsibilities:

• Develop, review, and maintain design control documentation in compliance with regulatory requirements, such as writing Design Input and Output documentation, Production Transfer documentation, protocols and reports including data analysis for stability, verification and validation studies of antibody assays for diagnostic use.

• Collaborate with cross-functional teams to ensure documentation accuracy and completeness.

• Support the design and development process by providing expertise in documentation standards and practices.

• Ensure timely updates and revisions of documentation as needed.

About Our Team:

 The Reagent Design team is part of the New Product Introduction R&D department. We are a team of 11 employees skilled in design control documentation of assays for diagnostic use within the fields of tissue-based pathology assays such as immunohistochemistry and ISH/FISH molecular assays. Our team is dedicated to excellence and innovation in medical diagnostics.

Work Environment:

 We cultivate a collaborative and supportive work environment where teamwork and cross-functional collaboration are highly valued. This approach not only enhances creativity but also ensures that everyone feels valued and supported in their roles.

Qualifications

• Master's degree or higher in a relevant field (e.g., Biochemistry, Biomedical Engineering, or related discipline).

• Experience with design control documentation in the medical device industry.

• Knowledge of regulatory requirements and standards (e.g., ISO 13485, FDA 21 CFR Part 820).

• Familiarity with immunohistochemistry and ISH/FISH molecular assays is highly desirable.

• Strong attention to detail and excellent organizational skills.

• Ability to work independently and as part of a team.

• Excellent written and verbal communication skills in English.

What We Offer:

• A chance to be part of New Product Introduction R&D developing products to the benefit of cancer patients, worldwide

• A position in an international and dynamic working place with exciting challenges and opportunities

• Great colleagues and a strong team spirit

• Many opportunities for personal career and expertise development

• Outstanding company culture

• Company pension scheme, individual bonus plan, private health care, medical & life insurance

Additional Details

This job has a full time weekly schedule.

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/locations

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Travel Required:

Occasional

Shift:

Day

Duration:

No End Date:

Job Function:

R&D