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Validation Engineer

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ATOS MEDICAL AB

At Atos Medical, we're ramping up our focus on introducing new products and equipment to our production line in the upcoming years. This expansion calls for a new Validation Engineer to join our team.Are you passionate about validation and well-versed in the regulatory landscape of medical devices? Do you excel at finding order in chaos and bureaucracy? Are you also ready to embark on new career adventures, then stay put and look at this new job at Atos Medical.About the RoleYou will be joining our Sustaining Engineering Team, which is a part of Quality Assurance, comprising 12 members with diverse backgrounds, handling technical files, change orders, complaints, process validations, PMS, and labeling. Currently, our team includes two validation engineers, and we are looking forward to welcoming a new team member. Your role involves close collaboration with various teams: Sustaining Engineering, Production, Process Development, Supply Chain, R&D, and other departments. Your ResponsibilitiesLead and manage validation activities for existing and new products in R&D projects.Plan, execute, and document validation activities following established procedures.Identify the need for validating new and existing processes.Update relevant technical product documentation.Drive the completion of process risk analyses for validated processes.Perform validation measurements, mainly within injection molding, and conduct statistical analyses on the results.Work in compliance with applicable standards and procedures.Collaborate closely with Change Control Owners in Sustaining Engineering, Production, and Process Development.The role is based in Hörby, Sweden and we adopt a hybrid working model, offering flexibility between locations like Hörby, our HQ in Hyllie or your home office. Typically, the team works 3-4 days in Hörby.About YouAt Atos Medical, each team member's contribution counts toward our success. As one of three Validation Engineers, you'll need to confidently shoulder responsibility for your tasks while being an effective team player.We're seeking someone experienced with strong validation and production knowledge, skilled in documentation, comfortable working independently on multiple tasks, and capable of prioritizing and delivering within deadlines.Experience is valuable, but more critical is personal suitability, dedication, and enthusiasm. However, to be successful we believe you need to check most of the boxes in our wish list:A Master of Science degree or equivalent in fields like production or mechanical engineering, or relevant work experience.Experience in validation of production processes, software, test methods, validation measurement, measuring equipment, and statistical analyses.Previous work with medical devices.Knowledge of standards like ISO13485 and MDR.Fluency in both spoken and written Swedish and English.Proficiency in using MiniTab or similar tools.Additional qualifying factors include material knowledge, particularly polymers, silicones, adhesives, and familiarity with injection molding.Ready for this challenge? Send in your application by January 31st; we're reviewing applications continuously. For more information, reach out to Petter Solding, Sustaining Engineering Manager, at [email protected]. Join us at Atos Medical!

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ATOS MEDICAL AB

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