Agilent
R&D Software Design Control Specialist - Medical Devices
Denmark · Work style not stated · Full time
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About the role
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- EmployerAgilent
- LocationDenmark
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
Job Description
Want to go further in Research & Development for Medical Devices and IVDs?Here'swhere you take the next step, working with the pioneering teams taking Agilent's world-leading products from the drawing board to the real world.
We are seeking atemporaryR&DSoftwareDesign Control Specialistfor oursoftwareteaminGlostrup,Denmarkwhich 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 specialist,you will workwiththeteam to drive activities and projects related to oursoftwareportfolio:
Software improvement projects/activitiese.g.,feature enhancements and design optimizations based on customer feedback
Show full description
Software innovation projectse.g.new product introductions
Software product care/sustaining activities
Design Control anddesign 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 thatAgilent’s pathologysoftwareproductsare in compliance withregulatory requirements.
Contribute tothe productDDF (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,Global Service,Usabilityand solutionspecialists
Qualifications
Ideally anengineering university degreeinIT/Computer/Softwareor aLife Science field
Abackgroundinsoftwarewithknowledgeinproduct developmentandsustaining/maintenance.
Experience withdesign controlincludingrequirements engineering,design verification,change control,product risk management,Defectmanagementand documentationwithmedicaldevices(IVD).
Experiencefrom aregulated environment.Ex.Medical Devices,Pharmaor similar.
Excellent English verbal/written communications skills.
PreferablyKnowledge of medical standards(IEC62304and ISO 14971)
Preferably experience with Agile software development
On a personal level you must be good atdriving your activities whilecommunicatingand coordinating with various stakeholders withinand external tothe organization. You arededicated anddriven byresults, which you reach by workingcloselywithyour colleagues withinthe team, as well as the rest of the organization.
You are well-structured and have a systematic way of working,seekingsimple and effective solutions within the complexity that surrounds a medical device and the accompanying documentation package. Youcanwork with day-to-day deadlinesand changing priorities,as well asinprojects 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 internationalorganization, offering a dynamic working environment, with exciting challenges and opportunities
Questions:
For anyquestions, please contactthe hiring manager,Jens Ole MadsenviaemailatJens-Ole.Madsen@agilent.com.
Application:
We will review applicationscontinuouslyso please send us your CV and cover letter as soon as possible via our recruitment system. We are looking forward to hearing from you.
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:
Occasional
Shift:
Day
Duration:
Over 12 Months
Job Function:
R&D
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At a glance
- Employment typeFull time
- Employer posted
- Added to ROLIVA
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Skills in this posting
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