{"id":3271166,"url":"https://alion.io/job/coloplast-systems-engineers","title":"Systems Engineers","company":{"id":13696,"name":"Coloplast","domain":"coloplast.com","url":"https://alion.io/company/coloplast","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":{"grade":"A","score":100,"open_postings":3,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":21,"computed_at":"2026-10-30T05:48:23Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Humlebæk, Denmark"],"countries":["DK"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":98000,"max_usd":201000,"period":"year","method":"role_country_seniority_unknown","sample_n":17},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design Controls","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-23T02:00:00Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-30T15:32:54Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"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?\nJoining 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.\nAbout the role\nWe 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.\nYour responsibilities:\nDrive and support design control and product risk management activities in development projects.\nTranslate stakeholders into clear, high-quality system and subsystem requirements with end-to-end traceability.\nOwn and contribute to systems engineering documentation, including design input/output, product description, and risk documentation.\nSupport design verification and validation planning and execution in close collaboration with Test Engineering.\nParticipate in design reviews, change control, and impact assessments.\nEnsure compliance with applicable regulatory and quality requirements (e.g. MDR, FDA, ISO 13485, ISO 14971).\nCollaborate closely with cross-functional project teams to support timely project execution.\nYour background\nDegree in engineering or a similar technical discipline.\nExperience with systems engineering and design control in a regulated environment required for permanent position (medical devices are an advantage).\nKnowledge of risk management, requirements engineering, and traceability.\nExperience working cross-functionally with R&D, Test, Quality, and Regulatory stakeholders.\nStrong analytical and communication skills.\nExperience with Polarion or similar ALM tools is an advantage.\nWhat we offer\nA 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.\nInterested?\nIf you would like to know more about the position, please contact Simon Gadving Schmidt, Head of CC & BC Systems and Test Engineering . We will take candidates into the recruitment process continuously, so do not hesitate to apply. These positions will remain open until a suitable candidate is found.\nPursuing 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. \nColoplast 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. \nVisit us on Coloplast.com. \nWatch the film. 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