R&D Software Design Control Specialist - Medical Devices

Agilent Technologies; Glostrup Kommune; Hybrid; DKK 520,000 - 750,000; Full time

Benefits offered by this job

Outstanding company culture

Career development opportunities

Company pension scheme

Individual bonus plan

Private health care

Medical & life insurance

Job summary

Agilent Technologies in Glostrup, Denmark is seeking an R&D Software Design Control Specialist to drive design control activities for pathology software. You will ensure regulatory compliance and contribute to DHF/documentation while collaborating across departments.

The role requires a software background, experience in regulated environments, and strong English communication. Partial remote work up to 2 days a week is possible.

Qualifications

• 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 (Medical Devices, Pharma or similar).
• Excellent English verbal/written communications skills.
• Preferably knowledge of IEC 62304 and ISO 14971.
• Preferably experience with Agile software development.

Responsibilities

• 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 DHF (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

Skills

Background in software

Software product development

Agile software development

Excellent English communication

Education

Engineering university degree in 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 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

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 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

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 [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
Location: Denmark-Glostrup