R&D Software Design Control Specialist Medical Devices
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Job Location:
Monthly Salary:
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
Job Description
Want to go further in Research & Development for Medical Devices and IVDsHereswhere you take the next step working with the pioneering teams taking Agilents world-leading products from the drawing board to the real world.
We are seeking atemporaryR&DSoftwareDesign Control Specialistfor oursoftwareteaminGlostrupDenmarkwhich is part of Pathology R&D inourClinical Diagnostics Division.
We want tostrengthenoursoftwareLifecycleengineering activities to ensure efficient and successful progress in newandsustainsoftwareprojectsforourhigh-qualityportfolio ofpathologystaininginstrumentssoftwarefor cancer diagnostics.
Thejob andyourresponsibilities:
AsR&DSoftwareDesignControl specialistyou will workwiththeteam to drive activities and projects related to oursoftwareportfolio:
Software improvement projects/activitiese.g.feature enhancements and design optimizations based on customer feedback
Software innovation projectse.g.new product introductions
Software product care/sustaining activities
Design Control and design documentation
Thisposition isbased inGlostrup(Copenhagen) where partial remote work would bean option(up to 2 days a week).
Your taskswill include:
Executionofsoftwaredesigncontrolactivitiesadhering to Agilent Quality Management System.
Ensuring thatAgilents pathologysoftwareproductsare in compliance withregulatory requirements.
Contribute tothe product DHF and documentation according to internal and regulatory requirements.
Analyze and convert User needs to product requirementsanduser stories
Conductsoftwareand cybersecurityriskassessment for safety and effectiveness of the product
Collaboratewith Test and Validation responsiblefor design verification and validationexecution.
To succeed you collaborate with a broad range of stakeholders in the organizatione.g.Marketing Procurement Regulatory Affairs Quality Assurance Manufacturing Developers and Global ServiceUsabilityand solutionspecialists
Qualifications
Your qualifications:
Ideally an engineering university degree in IT/Computer/Software or a Life Science field
A background in software with knowledge in product development and sustaining/maintenance.
Experience with design control including requirements engineering design verification change control product risk management Defect management and documentation with medical devices (IVD).
Experience from a regulated environment. Ex. Medical Devices Pharma or similar.
Excellent English verbal/written communications skills.
Preferably Knowledge of medical standards (IEC 62304 and ISO 14971)
Preferably experience with Agile software development
On a personal level you must be good at driving your activities while communicating and coordinating with various stakeholders within and external to the organization. You are dedicated and driven by results which you reach by working closely with your colleagues within the team as well as the rest of the organization.
You are well-structured and have a systematic way of working seeking simple and effective solutions within the complexity that surrounds a medical device and the accompanying documentation package. You can work with day-to-day deadlines and changing priorities as well as in projects with longer duration.
We offer:
- Outstanding company culture
- Career development opportunities
- Company pension scheme individual bonus plan private health care medical & life insurance
- A position within an international organization offering a dynamic working environment with exciting challenges and opportunities
Questions:
For any questions please contact the hiring manager Jens Ole Madsen via email at .
Application:
We will review applications continuously so please send us your CV and cover letter as soon as possible via our recruitment system. We are looking forward to hearing from you.
About Agilent:
Agilent inspires and supports discoveries that advance the quality of life. We provide life science diagnostic and applied chemical 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 .
Additional Details
This job has a full time weekly schedule.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:
OccasionalShift:
DayDuration:
Over 12 MonthsJob Function:
R&DRequired Experience:
IC
