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Design Control Specialist, Product Development
Coloplast A/S
Source: Headcount Labs · original listing ↗
Job data: Headcount Labs, ODbL 1.0. Job descriptions belong to their employers.
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About this role
At Atos Medical, a Coloplast Group company, you will contribute to a business built on innovative solutions for people living with a neck stoma. Everything we do revolves around our end-users and how we empower them. This is our company-wide commitment. We actively engage with our end-users to understand their needs — and translate those insights into better outcomes. Would you like to shape robust medical devices through systems thinking and design control? Join the Atos R&D team in Hörby and take on a key role in developing safe, effective, and compliant medical devices for people living with a laryngectomy. You will work across systems engineering, design control, usability, and risk management, helping to translate user needs into well-defined requirements and robust product solutions. About the Role We are looking for a Design Control Specialist who enjoys bringing people, technology, and documentation together throughout the product lifecycle. In this role, you will translate user needs into clear product and system requirements, support architecture and interface decisions, and ensure traceability from requirements through risk controls, verification, and validation. You will work closely with colleagues across R&D, Quality, Regulatory Affairs, Scientific Managers and Product Management, helping to create clarity in complex development projects. Your main responsibilities include: • Lead design control activities and facilitate design reviews and change controls in cross-functional development projects. • Elicit, analyze, document, and manage user needs, product requirements, and interfaces. • Establish and maintain end-to-end traceability between requirements, design outputs, risks, verification, and validation evidence. • Structure technical documentation for product families that share components, subsystems, interfaces, accessories, or compatible products. • Assess technical changes and make dependencies, ownership, and potential device and portfolio impacts transparent. • Lead product risk management activities, including workshops, reviews, risk-control traceability, and maintenance of the risk management file. • Collaborate with external development partners by aligning technical expectations, reviewing deliverables, and integrating their work into our quality system. The role is based in Hörby , with our hybrid model typically requiring three days on site per week . About You You may come from design control, systems engineering, quality engineering, mechanical engineering, electronics engineering, or another technical field. What matters most is your ability to understand how requirements, design decisions, product risks, interfaces, and evidence connect, and your willingness to create clarity and structure across different disciplines. You enjoy working in a collaborative environment, asking the questions that help uncover gaps, challenge assumptions, and move projects forward. We imagine that you: • Hold a degree in systems engineering, mechanical engineering, electronics engineering, quality engineering, biomedical engineering, life science, or a related discipline. • Have experience with product development, systems engineering, quality engineering, design control, requirements engineering, product risk management or technical project work. • Can work with complex mechanical or electronic products, or multidisciplinary systems combining several technologies. • Understand requirements management, interfaces, traceability, risk management, verification, validation, and design reviews. • Are comfortable structuring technical documentation and evaluating changes across products with shared components or compatibility dependencies. • Communicate clearly and are fluent in written and spoken English. Experience from medical devices or another regulated industry is an advantage, particularly familiarity with design controls, ISO 13485, ISO 14971, the EU MDR, or applicable FDA quality system requirements. You Will Stand Out If You • Combine technical judgement with curiosity and strong collaboration skills, bringing specialists together. • Ask the questions that uncover gaps, challenge assumptions, and help teams reach clear, practical, and compliant solutions. • Take ownership of the technical documentation, from creating and maintaining the documentation to ensuring that stakeholders understand the technical decisions, rationale, and consequences behind it. • See the connections between requirements, risks, and technical decisions and bring structure and clarity to complex topics. Depending on the experience and expertise you bring, the position may be offered at a senior level. What We Offer You will join a collaborative and friendly workplace where your expertise and contribution help shape the future of medical device development. You will work closely with knowledgeable colleagues across functions and be part of an environment where curiosity, teamwork, and continuous learning are highly valued. We offer employment conditions through a collective agreement, flexible working hours, and benefits that support your wellbeing and everyday life. These include an Epassi lunch benefit, a wellness allowance, and breakfast at the office several times a week. How to apply We work with continuous selection, so we encourage you to submit your application as soon as possible. Please apply with your CV only. We do not ask for a cover letter. Instead, feel free to include a short summary at the top of your CV, highlighting your experience and motivation relevant to this position. If have questions about the role, feel free to reach out to hiring manager, Rikke Gleerup Ovesen, rikkegleerup.ovesen@atosmedical.com . Want to learn more about life at Atos? Visit our testimonial pages to explore our people and our culture – Life at Atos - Atos Medical We aim to manage this recruitment without the support of external agencies. Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox®, Provox Life™ and Tracoe. We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business. Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma. Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S 62480 LI-AT