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Visar 5 av 5 lediga jobb för "Civilingenjör, medicinsk teknik"
Rensa sökfilterProduction Support Engineer
When you can’t breathe, nothing else matters. That’s why a career at Breas Medical matters. Our mission is to improve the quality of life and care of respiratory patients around the world through a personal commitment to innovation, quality and customer focus. Are you our next Production Support Engineer? Are you an engineer who enjoys solving technical challenges and turning ideas into reliable manufacturing solutions? You may already have experience in production or manufacturing engineering, or you may be at the beginning of your career with a relevant technical education and an interest in medical technology. As a Production Support Engineer within R&D Sweden, you will play an important role in strengthening our production processes and supporting the introduction of new products and design changes. Working closely with Production, R&D, Quality and other cross-functional teams, you will help ensure that our products are manufactured safely, efficiently and in accordance with applicable quality and regulatory requirements. This is an opportunity to combine hands-on production support with continuous improvement, technical problem-solving and long-term development in a highly regulated and meaningful industry. The position is full-time, permanent and based on-site at Breas Medical’s headquarters in Mölnlycke, Sweden. Main responsibilities Provide technical support to Production and help resolve manufacturing and quality-related issues. Lead or support design transfers, new product introductions and the implementation of design changes. Develop and improve manufacturing processes, methods, tooling, equipment and work instructions. Plan, perform and document process, verification and validation activities. Analyse production performance and contribute to improvements in product quality, production yield, safety and cost efficiency. Support Lean initiatives and collaborate with cross-functional teams to achieve shared goals. About you You are a curious and solutions-oriented engineer who enjoys turning technical challenges into practical improvements. You work in a structured way, with attention to quality, safety and documentation. Collaboration comes naturally to you, and you are comfortable communicating with colleagues across different functions and areas of expertise. You have an open mindset, enjoy working close to production and are motivated by contributing to products and processes that make a meaningful difference. To be successful in this role, we believe you bring some of the following experience and skills: A university degree in production engineering, medical engineering, mechanical engineering, electronics or another relevant technical field. Experience or a strong interest in production, manufacturing processes or medical technology. An understanding of mechanics, electronics and software, and how these areas interact within a product. Experience or knowledge of Design for Manufacturing, design transfer, verification, validation, tooling or process development. A structured approach to problem-solving and technical documentation. Good spoken and written Swedish and English. Previous experience in production or manufacturing engineering is an advantage but not essential. We also welcome applications from recent graduates with a relevant educational background and an interest in developing within production engineering and medical technology. Knowledge of regulatory requirements and standards for medical devices, such as ISO 13485, MDR, IEC 60601-1 or FDA requirements, is considered an advantage. Be More with us Join Breas and become part of a company where your experience, ideas and ambition can make a meaningful difference. Apply today and explore what it means to Be More. Expected recruitment timeline Applications will be reviewed continuously. More about us Founded in 1991 in Gothenburg, Sweden, Breas Medical is a global specialist in home mechanical ventilation and airway clearance, with a growing portfolio of sleep therapy solutions. Our purpose is to help the world breathe better. We connect people throughout the respiratory journey by bringing together insights, innovation and care. Our solutions form a connected ecosystem that includes ventilation, airway clearance, interfaces, accessories, connectivity, services and clinical education, supporting patients, caregivers and healthcare professionals from therapy initiation to long-term care at home. Headquartered in Sweden, Breas has more than 300 employees and subsidiaries across Europe, Asia-Pacific and the Americas. Together with our network of specialised distributors, we serve customers in over 40 countries worldwide. Find out more: Breas Medical
Medtech Specialist
Job description MedTech Specialist - Consultant Opportunities Join Our Team at Randstad Life Sciences Randstad Life Sciences is looking for experienced and motivated MedTech professionals for future consultant assignments in the Gothenburg area. At Randstad Life Sciences, we are dedicated to helping you advance your career and achieve your goals. As a consultant with us, you will enjoy competitive compensation, valuable benefits, and the security of collective agreements. Your dedicated consultant manager will guide you throughout your journey, connecting you with diverse, rewarding assignments across leading life sciences organizations. Through our vast professional network, ongoing learning opportunities, and personalized support, we empower you to continuously grow and make an impact in your field. Please note that this is an open, proactive posting for future assignments. While scope and duration vary by client, typical engagements last approximately 6 months. We seek professionals across all levels of seniority to contribute to critical projects, ranging from R&D and laboratory work to quality assurance and clinical research. You will collaborate in cross-functional teams and with internal and external stakeholders. You are expected to follow strict and detailed regulatory standards and maintain precise documentation. You are a science-driven professional with a proactive mindset. You excel both independently and in team settings, demonstrating flexibility, curiosity, and a strong sense of responsibility. You are adept at building relationships and navigating complex stakeholder landscapes. At Randstad Life Sciences, we focus on specialized expertise as part of Randstad, a global leader in talent solutions dedicated to becoming the world's most equitable and focused talent organization. Based in the Netherlands, Randstad spans 39 markets with roughly 40,000 employees worldwide. By combining our expansive global reach with strong local connections, we deliver rewarding opportunities for academics and specialists. As your dedicated talent partner, we empower you to advance your career, acquire key skills, and thrive in a meaningful professional environment. At Randstad Life Science, we are committed to equity and diversity. We value individuality and welcome applications from all qualified candidates. Deadline: 2026-10-18, selection process and interviews will be ongoing, so please apply as soon as possible. For questions, please contact Klara Danielsson Please note: Applications sent via email will not be processed and will be deleted in accordance with GDPR compliance. Responsibilities Contribute to the development, testing, and quality assurance of medical devices and processes, adhering to strict regulatory standards and directives Maintain precise documentation in compliance with both company protocols and global regulatory requirements Collaborate effectively with internal and external stakeholders to drive project success Engage proactively in technical and cross-functional teams to build and maintain professional networks Qualifications MSc or engineering degree Medical Technology, Biotechnology, Chemistry, Pharmacy, or a closely related, relevant field 5-8 years documented professional experience within a medical technology company, specifically in the development, manufacture, or research of medical devices or services High level of attention to detail and accuracy Proficient in both English and Swedish (written and verbal) About the company Randstad På Randstad vet vi att alla människor har en plats på arbetsmarknaden. Med verksamhet över hela landet och inom alla kompetensområden hjälper vi människor att hitta ett jobb som känns bra, och där de får möjlighet att växa, utvecklas och uppnå sin fulla potential. Med närmare 600 000 anställda i 38 länder är Randstad världsledande inom HR-tjänster, med målsättningen att bli världens främsta och mest uppskattade partner på arbetsmarknaden. Genom att kombinera vår passion för människor med kraften i dagens teknologi hjälper vi människor och företag att uppnå deras fulla potential. Vi kallar det Human Forward.
Junior R&D ingenjör
Integration Diagnostics and its core products, Penguin RFA and Osseo100 measures dental implant stability to enable clinicians to decide when to load an implant. The technique has been developed in close cooperation with clinicians and experts in the field of dental implantology. Resonance Frequency Analysis (RFA) and the measurement unit Implant Stability Quotient (ISQ) were introduced into the dental implant industry in 2001 and are now established methods of measuring implant stability and osseointegration. In 2015, in response to the dental community’s need for an accessible ISQ measuring system, Integration Diagnostics Sweden AB (IDSAB) was founded. Sales have developed rapidly with clients today in + 70 countries globally. In 2018, Integration Diagnostics became part of the Japanese company Nakanishi Inc. Nakanishi Inc., is a world-leading company of professional dental instruments with the world’s top-share brand “NSK”. All its products are developed and manufactured in Japan and distributed to 135 countries around the globe. The NSK Group has 14 subsidiaries worldwide and has established a strong global sales network. We are currently looking for a, Junior R&D Engineer – Medtech As a Junior R&D Engineer, you will be part of a small and agile R&D team, working closely with the R&D Director, who is also the founder of the company. This role offers a unique opportunity to gain hands-on experience across the entire product lifecycle, from concept development and testing to technical documentation and production support. You will play an active role in maintaining and improving existing products while supporting the development of future innovations within IDSAB's medical device portfolio. Key responsibilities: Contribute to the maintenance, optimization, and continuous improvement of commercially available products. Support the development and refinement of R&D methodologies, development processes, verification activities, and testing procedures in collaboration with the R&D team. Manage existing technical documentation and prepare new technical documentation when required. Work cross-functionally with colleagues in R&D, Quality Assurance, Production, and Product Management. In this position, your daily work has a wide scope and is conducted in a dynamic, innovative international working environment. Qualifications • Master of Science in Engineering (M.Sc.) or Bachelor of Science in Engineering (B.Sc.) in Electronics, Engineering Physics, Medical Engineering, or a related field. • Good knowledge about medical device development • Fluent in Swedish and English Preferred Experience The following experience is considered an advantage: Hands-on experience from experimental work, laboratory environments, or workshop activities. Practical experience gained through master's thesis projects, personal side projects, student competitions, or involvement in student organizations focused on engineering, electronics, robotics, or product development. Experience in prototyping, CAD, testing, troubleshooting, or building technical systems. Previous experience within the medical device industry is highly valued. To succeed in this role, you are a user- and patient centric person with a strong drive to provide innovative products. You have a broad technical interest, and you can navigate in both hardware and software development. You will be part of an exciting and challenging journey shaping the company’s future and taking the business to new heights. In this role you will have a great opportunity to make an impact and improve the products and solutions we supply to the market, and you will have a big variation in activities. Application To apply, please send your CV to career@idsab.com By submitting your application, you also consent to us storing your personal data, including CV & cover letter. You can revoke the consent whenever you want.
R&D Manager - Surgical Tables
Take the lead in shaping the future of surgical tables, combining hands-on product development with leadership of a skilled R&D team to deliver innovative solutions for operating rooms worldwide. Ready to make an impact? Join us. Stille AB is a Swedish medical device company with a long heritage in precision-engineered surgical instruments and operating tables, sold globally through leading distribution partners including GE HealthCare, Ziehm, Philips and Siemens Healthineers. Our Surgical Tables business unit designs and manufactures advanced OR and hybrid imaging tables — including the imagiQ3 platform with True Free Float® technology and the Medstone range — used in hospitals and imaging suites worldwide. Stille’s vision is to empower surgical excellence through products that enable the highest standards of care, fulfilling our promise: “Surgical Perfection. For Life.” The Role We are looking for an R&D Manager to lead the product life cycle management of our existing portfolio as well as the development of our next generation of surgical table platforms This is a hands-on role at the intersection of electromechanical engineering, project management and product cost strategy — owning both the technical integrity of our electromechanical systems and the on-time, on-budget delivery of development programs, from concept through design transfer and regulatory submission. You will lead a small R&D team while also being part of it yourself, with your own deliverables: balancing clinical performance, regulatory compliance, manufacturability and total cost of ownership. Key Responsibilities Lead a small R&D team with senior employees, setting technical direction across electrical, electromechanical, mechanical and software workstreams for surgical table platforms. Own project management of development programs: scope, timeline, budget, risk and stage-gate governance Drive electrical and electromechanical architecture decisions for motion control, power systems, control electronics and human-machine interfaces used in imagiQ3, Medstone and future platforms. Ensure development activity meets medical device regulatory and quality requirements, including IEC 60601-1/-2-46, ISO 13485, ISO 14971 (risk management), EU MDR and FDA design control requirements. Champion design-for-cost and design-for-manufacture (DFM/DFA) thinking from the earliest concept stage, working closely with sourcing and operations to hit target cost and margin goals without compromising quality and clinical performance. Engage directly with suppliers and contract manufacturers on component selection, make-vs-buy decisions, and design trade-offs that affect cost, lead time and supply resilience. Partner with Product Management, Regulatory Affairs, Quality and Commercial teams to translate market and clinical requirements into robust, manufacturable, cost-competitive designs. Manage external partners, test houses and imaging partners on interface and integration requirements. Own technical documentation, design history files and verification/validation planning in support of regulatory submissions. Report R&D program status, risks and resource needs to senior management and the board as required. What You Bring MSc in Electrical/Electronics Engineering, Mechatronics, Biomedical Engineering or a related discipline (or equivalent experience). Solid experience in electrical or electromechanical engineering for complex, regulated products — motion/motor control, power electronics, embedded systems or similar. Proven project/program management experience leading multidisciplinary engineering teams through the full development lifecycle, on time and on budget. A demonstrated cost-conscious engineering mindset — comfortable making design trade-offs against target cost, and working closely with commercial/sourcing/procurement or suppliers to get there. Strong communication skills in English and Swedish Genuine interest in both technology and people with strong communication and collaboration skills Solution-oriented and results-focused mindset building trust and lasting relationships with colleagues, partners and suppliers Nice to Have Direct sourcing, procurement or supplier-development experience, particularly for mechatronic or electromechanical subassemblies. Experience with capital medical equipment (imaging, OR equipment, patient positioning systems) Familiarity with PLM/PDM tools, formal DFMEA/risk management processes, and Lean/Six Sigma cost-reduction methods. What We Offer The opportunity to hands-on lead technical development of market-leading surgical table platforms used in hospitals worldwide, within a company that combines the agility of a mid-size organization with the reach of global partnerships. You'll have direct visibility to commercial and board-level strategy and a real mandate to shape how we build products — technically and commercially. At Stille, you will join a skilled and dedicated team where you can influence the future of our surgical table portfolio, contribute to meaningful innovation and grow professionally. Location: Torshälla/Eskilstuna, Sweden Reports to: VP Surgical Tables Apply Ready to make an impact, contribute to surgical perfection and be part of our exciting future within the Stille Group? If you match the profile above, we would be delighted to receive your application! Please submit your CV and cover letter through our website: https://stillegroup.careers.haileyhr.app/ by October 4th at the latest. We review applications and conduct interviews on an ongoing basis, and the position may therefore be filled before the closing date. We encourage you to apply as soon as possible. Please note that we kindly decline contact from recruitment agencies and providers of recruitment services.
Senior Medical Device Quality & Regulatory Engineer
Senior Medical Device Quality & Regulatory Engineer At Flow Neuroscience, we’re building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale. Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder. Following regulatory approvals in Europe, UK, Australia, and the US, we’re entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally. We’re now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure. The Role You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory. This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain. What You’ll Do Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control) Own and maintain Technical Documentation / Technical Files / DHFs / DMRs Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements Collaborate closely with R&D on design changes and process improvements Support and continuously improve our ISO 13485-certified QMS Support regulatory submissions and updates (EU MDR, FDA) Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness Work cross-functionally with product, regulatory, and operations teams What We’re Looking For You’re someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing. Core Competencies Very strong technical project management skills Strong technical experience with active medical devices Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820) Hands-on experience with supplier and manufacturing quality control Proven experience managing Technical Files / DHF / DMR Expertise in ISO 13485 QMS implementation and maintenance Experience with FDA regulations (QMSR) and EU MDR Experience with FDA inspections and/or Notified Body audits Bonus (Highly Valuable) Experience with FDA PMA devices (Class III) and PMA supplements Background in combination hardware/software medical devices Quality management system automation, eQMS & AI-tools. Experience working closely with Asia-based contract manufacturers Experience working with neurotech. Who You Are You take ownership and operate with high autonomy You’re structured, detail-oriented, and pragmatic You can translate regulatory requirements into efficient processes You enjoy working cross-functionally with engineers and operators You’re comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing Why join us? Work on a clinically proven treatment for one of the world’s largest health problems Be part of a company transitioning into global scale (including the US market) Own meaningful parts of the quality and regulatory backbone of a US Class III device Join a mission-driven team combining science, engineering, and real-world impact Location: Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.
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