Product Lifecycle Responsible R&D Scientist - Pathology

Job DescriptionAgilent 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.Will you join us in the fight against cancer?We are seeking an experienced R&D Scientist to take ownership of lifecycle responsibilities for one of our Pathology product lines. In this role, you will help sustain state-of-the-art in vitro diagnostic devices that make a real difference for patients worldwide.Your key responsibilities will include driving design control activities throughout the product lifecycle,maintaining and updating risk management files to ensure compliance. Supporting sustaining and enhancement activities to uphold product quality and performance.All work will be performed in alignment with relevant regulatory guidelines and industry standards.Your tasks will include:Planning, generation and update of Design Control documentation according to Agilent Quality Management System (QMS)Writing of study protocols and reports including data analysisDocument and specifications writingProduct care initiatives such as design changes to existing productsPost Market Surveillance activitiesComplaint handling when R&D support is needed for root cause investigationStakeholder management/communication (internal and external)The stakeholders for the product line you will be responsible of mainly are in US, so expect meetings late afternoon/evening from time to timeAct as subject matter expert during internal audits and external inspections. You will be based in our Glostrup, Denmark office, working in an exciting and dynamic diverse environment with around 25 colleagues. Our department is divided into two teams. The team you will join includes 11 Scientist,1 Lab tech coordinator and a manager.QualificationsWe are looking for a motivated individual with the following background:Master’s/PhD in Biology, Biochemistry, Biotechnology or similarProven experience of at least 1-2 years within design control of Medical/Diagnostic devicesKnowledge of IHC (Immunohistochemistry), ISH (in situ hybridization) or special stains is a plusKnowledge of Companion Diagnostic (CDx) reagents is a plusFull fluency in English. Note that Danish is not requiredOn a personal level, you are rigorous, driven and process oriented. You also have excellent interpersonal and communication skills to interact with many external and internal partners. You enjoy working both autonomously and as part of a team. Whilst being flexible and adaptable, you have also strong planning, organizational and time management skills.What we offer:Outstanding company cultureA position in an international and dynamic working place with exciting challenges and opportunitiesAn exciting and diverse work environment with many challenging tasksA chance to be part of the lifecycle support of state-of-the art IHC, ISH and primary stains products to the benefit of cancer patients, worldwideGreat colleagues and a strong team spiritMany opportunities for personal career and expertise developmentCompany pension scheme, individual bonus plan, private health care, medical & life insuranceWe will make sure you get the training and development opportunities you need to become the best in your field.Additional DetailsThis 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/locationsAgilent 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: OccasionalShift: DayDuration: No End DateJob Function: R&D