Systems Engineers

Coloplast; Humlebæk; On-site; DKK 600,000 - 900,000; Full time

Job summary

Coloplast in Humlebæk, Denmark, is seeking Systems Engineers to join our Systems & Test Engineering team within Product Development. We offer one permanent position and one 12-month maternity cover to strengthen our integrated design control and systems engineering effort, in close collaboration with R&D specialists, Test Engineering, QA, Regulatory Affairs and Project Management.

You will drive design control execution, develop end-to-end system requirements with traceability, participate in

Qualifications

• Degree in engineering or similar technical discipline.
• Experience with systems engineering and design control in regulated environments.
• Knowledge of risk management, requirements engineering, and traceability.
• Experience working cross-functionally with R&D, Test, Quality and Regulatory teams.
• Strong analytical and communication skills.
• Polarion/ALM tools experience is an advantage.

Responsibilities

• Drive and support design control and product risk management activities in development projects.
• Translate stakeholders into clear, high-quality system and subsystem requirements with end-to-end traceability.
• Own and contribute to systems engineering documentation, including design input/output, product description, and risk documentation.
• Support design verification and validation planning and execution in close collaboration with Test Engineering.
• Participate in design reviews, change control, and impact assessments.
• Ensure compliance with applicable regulatory and quality requirements (e.g. MDR, FDA, ISO 13485, ISO 14971).
• Collaborate closely with cross-functional project teams to support timely project execution.

Skills

Systems engineering

Design control

Regulatory awareness

Risk management

Requirements engineering

Traceability

Cross-functional collaboration

Analytical skills

Communication skills

Polarion/ALM tools

Education

Engineering degree

Tools

Polarion

Job description

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Would you like to enter a creative R&D environment where you participate in developing innovative solutions for people with intimate healthcare needs worldwide? And would you like to play a key part in integrating the systems engineering approach, allowing us to develop even better products? Is your Design control and risk management experience within non-digital medical devices?

Joining our dynamic department, you can look forward to becoming part of a great work environment where you will work alongside knowledgeable specialists and project managers.

About the role

We are looking for Systems Engineers for 1 permanent position and 1 12-months maternity cover position to strengthen our combined Systems & Test Engineering team in Product Development at Coloplast. The role supports ongoing development by driving systems engineering and design control execution in close collaboration with R&D specialists, Test Engineering, QA, Scientific Affairs, Regulatory Affairs, and Project Management.

Your responsibilities

• Drive and support design control and product risk management activities in development projects.
• Translate stakeholders into clear, high-quality system and subsystem requirements with end-to-end traceability.
• Own and contribute to systems engineering documentation, including design input/output, product description, and risk documentation.
• Support design verification and validation planning and execution in close collaboration with Test Engineering.
• Participate in design reviews, change control, and impact assessments.
• Ensure compliance with applicable regulatory and quality requirements (e.g. MDR, FDA, ISO 13485, ISO 14971).
• Collaborate closely with cross-functional project teams to support timely project execution.

Your background

• Degree in engineering or a similar technical discipline.
• Experience with systems engineering and design control in a regulated environment required for permanent position (medical devices are an advantage).
• Knowledge of risk management, requirements engineering, and traceability.
• Experience working cross-functionally with R&D, Test, Quality, and Regulatory stakeholders.
• Strong analytical and communication skills.
• Experience with Polarion or similar ALM tools is an advantage.

What we offer

A 12-months temporary position and a permanent position in a collaborative and learning environment with strong focus on quality, high professional standards, good sparring and learning. You will get real responsibility from the start and the opportunity to build strong capability in systems engineering and regulated product development. You will collaborate closely with experienced colleagues in Systems Engineering, Test Engineering, and Product Development.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world's leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because - and not despite - of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark