Baxter was founded 90 years ago and has approximately 60,000 employees worldwide. We save and sustain lives through medical innovations that today can be found in almost every hospital, clinic and home, worldwide.
At Baxter's site in Alvik, Luleå, about 130 people work to develop, improve and manufacture Liko's product portfolio of lifting aids. Together we create a place where we feel good, are successful and inspire each other to do good work. We are proud winners of the Swedish LEAN Award 2021.
The R&D Sustaining department, Luleå, is responsible for developing and improving our current product portfolio. This means driving through different types of projects with the goals of increasing customer satisfaction, raising product quality, optimizing product design and strengthening the competitiveness of our products. A major part of our responsibility is to ensure that we meet regulatory requirements in the different markets where we operate. We are currently 23 people, divided into two teams and working agile according to the Scrum model.
About the position
As a Validation & Verification Engineer, you ensure that our products meet set requirements and that the specifications of the product comply with the user's needs and intended uses. Specifically, this means:
- Updating requirements and risk documentation for our products and identifying the impact of projects on these.
- Planning verification, validation and actions to ensure that we reach set requirements and mitigate gaps against requirements or risks.
- Reviewer and Subject Matter Expert (SME) for design updates.
- Risk assessments for production deviations, CAPA, post market surveillance etc.
- Review and approval of verification and validation reports.
You will work in close collaboration with other functions.
You will work with medical devices such as lifting aids from Liko's product portfolio.
Your background
You are an engineer with a technical focus or equivalent experience and have 3-5 years of work experience, preferably in medical technology (MedTech) and product development, industry or equivalent. You are used to working in projects and have experience in risk management and working with product requirements or around product information (BOM, quality issues, statistics etc). It is a great advantage if you enjoy both theoretical and planning work. You should also be independent and used to planning your own work.
Who you are
You are structured and like to manage and coordinate a lot of information. You take ownership of your tasks and you plan, prioritize and drive your processes forward in an efficient way while never compromising on quality. You are a team player and are communicative in both speech and writing.
We offer you
An opportunity to be challenged and to grow in a world-leading medical technology company. You will work at our facility in Alvik outside Luleå. Flexible work (from home) 1-2 days per week is offered if the work allows and in consultation with the nearest manager.