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Embedded Systems Engineer

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Job Overview
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems for the past 30 years with more than 5 000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland with sites in Sweden, Taiwan, and the Unites States.
The Innovation team in Sweden is looking for a new co-worker focusing on electronic hardware and embedded software development. The team’s objective is to ideate and conceptualize future product offerings. Our focus is on injected drug delivery, enabling patient’s independence and wellbeing.
We are looking for an individual with deep interest in emerging technology and an open mindset, who enjoys working in the front end of technology and innovation. The work is done in projects together with colleagues from other disciplines, e.g., mechanics, industrial design. The job location is at SHL Medical’s design center in Nacka Strand.
Main Responsibilities
Specify, design, and develop electronics hardware for drug delivery devices.
Design, implement, and test software/firmware for embedded medical applications.
Supplier scouting and evaluation.
Testing and verification.
Evaluate new technology and solutions required to enhance product functionality and use experience.
Handover and support to the global development functions.

Skills and Qualification
Bachelor or master’s degree in Electronics Engineering with 5+ year’s product development experience.
Experience of Medical Devices, Healthcare or Pharmaceutics is a benefit (i.e., regulatory frameworks IEC 60601, ISO 13485 and IEC 62304), ideally in the development of handheld devices.
Experience from connectivity, IoT and digitalization is a benefit.
Strong communication and collaboration skills, with the ability to work both independently and as a part of a team.
Ability to structure, organize and lead projects.
Ability and willingness to work in a global structure.
Initiative and hands-on approach to address and solve complex problems.
Very good knowledge in English is required (spoken and written).
Keen interest in understanding customer needs and improving patients’ life.
Strong experience of following tools/technologies:
MS Office Suite, Adobe Creative Cloud, Miro
Electronic CAD programs, e.g., OrCAD, Altium Design, Mentor Graphics.
Embedded development, ARM architectures, C language, source code management (Git), unit testing techniques/frameworks, RTOS, Cybersecurity, IoT protocols

We Offer
Exciting opportunity in a fast-growing international medical device company
A modern working environment, with multicultural and dynamic teams
Flexible working hours and a hybrid remote work policy

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including CV, motivation letter and all other relevant documents to our Talent Acquisition Department at [email protected]
Please note: For this position we do not consider applications from recruitment agencies. Visa mindre

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Senior Specialist Regulatory Affairs

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Would you like to develop long term as part of a growth company, which continuously strengthens its position through innovative products? Then this is the position for you!
SHL Medical AB, part of SHL Medical, offers you a position in a dynamic environment where we develop and manufacture products that improve people’s health and quality of life. As an employee you take a great responsibility and join a global organization at an expanding stage. We are now seeking a Senior Specialist Regulatory Affairs for our office in Nacka Strand, Stockholm.
As a Senior Specialist within Regulatory Affairs, you will be part of a team of 3 highly skilled people and you will work closely together with the Quality Assurance team. Main focus will be to contribute to and support various development projects, throughout the product life cycle. This means interacting with most functions and departments at SHL Medical AB, such as Product Development, Project Management, Innovation, Business Development and so on. You will also be in contact with and provide support to customers and their RA representatives, as well as internally with our SHL colleagues in Taiwan, US and Switzerland.
As a Senior Specialist Regulatory Affairs, you carry out various work tasks, for example:
Act as company liaison with regulatory health authorities. Develop regulatory strategic plans specific to development programs.
Lead and author delivery of regulatory submission dossiers. Drive and implement process and system improvements to ensure successful submission outcomes.
Ensure applicable regulations and standards are integrated within the organization by e.g. participate in standardization organizations.
Guide the organization including management teams to ensure that SHL complies with up-to-date regulations and standards pertaining medical device and other products or services.
Management of SHL's certificates, authorizations, device registration etc.
Provide input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submission and approval.
Acting as coordinator and/or single contact point < SHL-Customer/Authority > in submission process.
Directly involved in the preparation, assembly and submission of all global regulatory documents, such as MAF, CTD and other international regulatory submissions in various countries.

We see that you have a background within QARA, and that you have a MsC or corresponding work experience. You are fluent in English, in speech and writing. We highly value experience within the medical device field and/or experience from working with pharmaceutical companies. You have strong communication skills and have the will and ability to work and collaborate in a global company.
Would you like to know more? Please visit our website or follow us on LinkedIn.
We welcome your application! Visa mindre

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