R&D Software Design Control Specialist - Medical Devices

DK05 DAKO Denmark R&D & Manufacturing; Glostrup Kommune; On-site; DKK 650,000 - 850,000; Full time

Benefits offered by this job

Company pension scheme

Bonus plan

Private health care

Medical & life insurance

Job summary

Agilent Technologies Inc. is seeking a temporary R&D Software Design Control Specialist in Glostrup, Denmark, to strengthen software lifecycle engineering for pathology software in the Clinical Diagnostics Division.

You will translate user needs into product requirements, manage design control documentation, and ensure regulatory compliance. You will collaborate with cross-functional teams, participate in risk assessments, and support verification and validation activities in a regulated

Qualifications

• Engineering degree in IT/Computer/Software or Life Science
• Experience in software with product development and maintenance
• Design control experience for medical devices (IVD)
• Experience in regulated environments (medical devices, pharma)
• Strong English communication skills
• Familiarity with medical standards IEC 62304 and ISO 14971
• Preferably experience with Agile software development

Responsibilities

• Execute software design control activities per Agilent Quality Management System
• Ensure pathology software products meet regulatory requirements
• Contribute to the DHF/ DDF documentation and regulatory compliance
• Translate user needs into product requirements and user stories
• Perform software and cybersecurity risk assessments
• Collaborate with test and validation for design verification and validation

Skills

Software engineering

Product development

Design control

Regulated environment

English communication

IEC 62304 ISO 14971

Agile development

Education

Engineering degree IT/Software or Life Science

Job description

Job Description Want to go further in Research & Development for Medical Devices and IVDs? Here's where 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 a temporary R&D Software Design Control Specialist for our software team in Glostrup, Denmark which is part of Pathology R&D in our Clinical Diagnostics Division.

We want to strengthen our software Lifecycle engineering activities to ensure efficient and successful progress in new and sustain software projects for our high-quality portfolio of pathology staining instruments software for cancer diagnostics.

The job and your responsibilities:

• Software improvement projects/activities e.g., feature enhancements and design optimizations based on customer feedback
• Software innovation projects e.g. new product introductions
• Software product care/sustaining activities
• Design Control and design documentation

Your tasks will include:

• Execution of software design control activities adhering to Agilent Quality Management System.
• Ensuring that Agilent's pathology software products are in compliance with regulatory requirements.
• Contribute to the product DDF (DHF) and documentation according to internal and regulatory requirements.
• Analyze and convert User needs to product requirements and user stories
• Conduct software and cybersecurity risk assessment for safety and effectiveness of the product
• Collaborate with Test and Validation responsible for design verification and validation execution.

To succeed, you collaborate with a broad range of stakeholders in the organization e.g. Marketing, Procurement, Regulatory Affairs, Quality Assurance, Manufacturing, Developers, Global Service, Usability and solution specialists.

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.

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

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

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

As a global leader in laboratory and clinical technologies, we are passionate about bringing great science to life. Our commitment to quality and innovation supports cutting-edge life science research, patient diagnostics, and ensures the safety of water, food, and pharmaceuticals. As scientists and clinicians pursue small, everyday advances and life-changing discoveries, we provide trusted answers to their most critical questions and challenges. Leveraging more than 50 years of expertise, we create advanced instruments, software, and consumables supported by teams of highly skilled and knowledgeable people. With 18,000 employees around the world, our global reach and comprehensive solutions provide the most reliable and accurate results, as well as optimal scientific, economic, and operational outcomes. We work collaboratively with our customers on their journey to make a real difference in human lives. Our culture is founded on trust, respect, and uncompromising integrity, and we pride ourselves on being a dynamic and inclusive workplace that celebrates diversity and fosters innovation. We can't wait for you to join us as we continue our mission to improve the world around us. Information about Agilent is available at Agilent.com.