R&D Software Design Control Specialist - Medical Devices

Agilent; Denmark; Hybrid; DKK 600,000 - 900,000; Full time

Benefits offered by this job

Pension plan

Private health care

Career development

Job summary

Agilent seeks an R&D Software Design Control Specialist in Glostrup, Denmark, to drive design controls for pathology software used in cancer diagnostics. You will ensure regulatory compliance and contribute to DHF/DDF documentation, working with cross-functional teams and external stakeholders.

Ideal candidates hold an engineering degree with experience in software within a regulated medical device environment, familiarity with IEC 62304, and strong English communication.

Qualifications

• Engineering degree in IT/Computer/Software or Life Science.
• Experience in software development in a regulated medical device environment.
• Knowledge of design controls: requirements, verification, change control, risk management and documentation.
• IEC 62304 / ISO 14971 knowledge preferred.
• Excellent English communication skills.

Responsibilities

• Drive software design control activities per Agilent QMS.
• Ensure pathology software products meet regulatory requirements.
• Contribute to product documentation (DDF/DHF) and regulatory filings.
• Translate user needs into product requirements and user stories.
• Collaborate with test/validation teams on design verification and validation.
• Coordinate with stakeholders across Marketing, Regulatory, Quality, Manufacturing and Development.

Skills

Design control

Regulatory knowledge

Agile methodologies

Stakeholder communication

Education

Engineering degree IT/Computer/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 s oftware team in Glostrup , Denmark which is part of Pathology R&D in o ur 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 p athology staining i nstruments software for cancer diagnostics.

The j ob and y our r esponsibilities:

As R&D Software Design Control specialist, you will work with the team to drive activities and projects related to our software portfolio :

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

This position is based in Glostrup (Copenhagen), where partial remote work would be an option (up to 2 days a week).

Your t ask s will include:

E xecut ion o f 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 d ocumentation according to internal and regulatory requirements .

Analyze and convert User needs to product requirements and user stories

Conduct software and cybersecurity r isk a ssessment for safety and effectiveness of the product

C ollab orate with Test and Validation responsible for design verification and validation ex ecution .

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

Qualifications

Ideally a n engineering u niversity degree in IT/Computer/Software or a Life Science field

A background in s oftware with knowledge in product development and sustaining/maintenance .

E xperience with design control incl uding requirements engineering , design verification , change control , product risk management , Defect management and documentation with medical devices (IVD) .

E xperience 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 devel opm ent

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 tea m, 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 [e-mail] .

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