Senior R&D Project ManagerSamanTree Medical (Switzerland) SA • Lausanne, Vaud, Switzerland

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Senior R&D Project Manager

SamanTree Medical (Switzerland) SA

Lausanne, Vaud, Switzerland

Lausanne, Vaud, Switzerland

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Senior R&D Project ManagerJoin a Team X Surgery Through Advanced ImagingSamanTree Medical is a held Belgian-Swiss medical device company to improving precision in surgery through imaging solutions. Headquartered in Liège, Belgium, X &D in Lausanne, Switzerland, and regional headquarters in Boston, our team X by a shared mission to bring clarity, speed, and confidence to the develop and manufacture the Histolog Scanner, a groundbreaking rapid, high-resolution imaging system X -time X tissue. These images assist physicians in making informed decisions influence outcomes for and Histolog Scanner is the first and only device built on massively parallel confocal microscopy, a revolutionary technology captures nearly 30,000 to high-resolution images in about one minute. Commercialized in Europe, the United and several additional geographies the Histolog Scanner represents a new standard in digital tissue imaging-combining speed, high-resolution and ease of use to optimize surgical and SamanTree, we imagine a world where every surgical decision is made with confidence and every leaves the room X surgeon "got it all". Our work is driven by a deep commitment to physicians and their center of every We move quickly and purposefully because time X . We strive for excellence and precision in every image, every line of code, and every interaction. We value curiosity, adaptability, and teamwork, knowing the best ideas come X integrity. Above all, we build technology earns trust-helping healthcare professionals deliver better outcomes, you re inspired by technology improves lives and by work blends scientific rigor with real human impact, we d love to meet you. Join us in shaping the future of surgical imaging and advancing precision in surgical Senior R&D Project Manager, Lausanne (Switzerland)As Senior R&D Project Manager for the Histolog consumable accessories you will be an integral part of SamanTree Medical s R&D team, X responsibility for the development, and manufacturing of these accessory products for the Histolog this role, you will lead and in the development of IVD/MD X design control, in accordance with ISOand Good Manufacturing Practices (GMP). You will in requirements definition, risk analysis, reagent and quality control method development, manufacturing development and scale-up, troubleshooting, and and activities to manufacturing and quality control testing. You will establish and maintain contract with manufacturing .This position requires leadership, written and verbal skills. to detail, ability to multi-task, and flexibility to adapt to changes in priority and schedules are Senior R&D Project Manager reports to the Head of Hardware Engineering.ResponsibilitiesLead and in development of IVD/MD X under design control, in accordance with ISOfrom X definition to production transfer.Produce and maintain technical file compliance with EC IVD (MDR) and (IVDR) and FDA and manage contract manufacturing and maintain quality proceduresDiscuss and solve complex problems X , sub-contractors, suppliers and customersConduct training of other employees or third partiesConduct internal and supplier auditsLead and/or in the Company products or in the management of controlled equipment (such as activities, the supply chain for the accessories in scope.Supports the commercial launch of the accessories in part of SamanTree Medical s R&D team, X also in the design, development and service activities for other is a position based on full responsibility for SamanTree Medical s accessory products:Handles detailed, complex concepts and problems, balances multiple tasks and implements programs. X and with Head of Hardware Engineering, R&D personnel and suppliers. Develops smooth and constructive with colleagues, outside agencies, and and meets deadlines.Conveys a professional and positive image and regarding SamanTree Medical and the not-for-profit and for-profit sectors. commitment to continued professional growth and , and ExperienceMinimum X s degree (advanced degree desirable) in a Technical discipline (Physical or Life Sciences, Engineering). Master s degree least 5 years of relevant industry background in product development under ISOand/or Good Manufacturing Practices (GMP), ideally with kits/procedure packs.Experience in writing technical file of IVD/MD X .Concrete experience with logistics constraints and packaging design and testing (including blister packaging).Knowledge of plastic injection molding and/or manufacturing process of medical device partsAbility to plan and levels.Ability to maintain open, constructive and with colleagues, management, and suppliers.Ability to prioritize and adapt to changing priorities while maintaining a high standard on experience in a startup environment is in French and English least Level B2), both oral and offerA full-time X salary package in line with your profile and experienceA human-size, dynamic, respectful, and work exposure, with learning and development role directly contributes to the improvement of global healthcare outcomesHow to ApplyPlease submit your resume X cover letter detailing your relevant experience and language will be reviewed on a rolling Opportunity are all proud to work for such a company as Samantree Medical. And we would be even prouder to have you on board. Whoever you are, wherever you come from, X your race, religion, color, sex (including pregnancy and gender identity), origin, political sexual marital disability, genetic age, membership in an employee parental military service, or other non-merit factor. Please apply if you see a position makes your and if you feel the role is appealing to you. If you re smart and you do, come X are.SamanTree is an emerging company with significant potential in the MedTech sector. For individuals seeking challenges, SamanTree offers opportunities for growth both and We value inquisitive and highly committed individuals who are to towards making SamanTree a a team X in healthcare. Together, let s shape the future of rapid tissue imaging for assessment of surgical margins with the Histolog Scanner. jidda1a48caen jit0310aen jpiy26aen

Lausanne, Vaud, Switzerland

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English

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