Research and Development Engineer in Umeå or Linköping

Description:

Now we are looking for an R&D Engineer at Nordic Biomarker with a focus on CE marking according to IVDR! Do you want to be part of developing future solutions in coagulation diagnostics – from idea to finished product, while also contributing to ensuring that our products meet the high requirements of IVDR? With the world as our market, Nordic Biomarker is a small large company within Life Science that develops, manufactures, and sells quality products for coagulation diagnostics all under one roof. You are welcome to a workplace characterized by family spirit, good collaboration, engaged colleagues, and pride in the societal value of our products. This is a permanent position with possible placement in Umeå or Linköping. We warmly welcome your application! About the Role As a project manager in the research and development department, you are responsible for projects related to CE marking according to IVDR of products in coagulation diagnostics. The projects may include CE marking of new reagents, updating existing products for CE marking according to IVDR (previously IVDD), and product modifications, such as customer-customized kits or new reagent and instrument combinations. The projects encompass work throughout the development and regulatory process, from planning and requirement specification to verification, documentation, and final CE marking. You play a central role in ensuring that products meet regulatory requirements and that necessary technical documentation is developed. You are responsible for planning, coordinating, and driving the projects forward in close collaboration with other departments. The role also includes developing and compiling technical documentation, leading and documenting risk management according to applicable standards, and planning and coordinating activities related to analytical performance evaluation. When needed in projects, there is an opportunity to participate in laboratory work. You also ensure that projects are delivered on schedule and according to established goals. Since the role involves close collaboration with other functions in the company, your communication skills and unpretentious working style are crucial. With many internal contact points, you will have the opportunity to work together with experts in several areas such as Production, QA, and Market. We are looking for you who · Hold a university degree in biochemistry, biotechnology, or equivalent · Have experience with project management, preferably within product development or regulatory work · Are structured, thorough, and have the ability to drive work forward · Are proactive and solution-oriented · Have good collaboration skills and enjoy working in cross-functional teams In this recruitment, we place great emphasis on your personal qualities. Commitment and a genuine interest in the work are central characteristics that define you. Meritorious · Experience in in vitro diagnostics or related field · Experience working within quality management systems, preferably according to ISO 13485 · Experience with EU regulations for in vitro diagnostics (IVDR) · Experience working with regulatory requirements outside the EU, for example FDA Salary Range At Nordic Biomarker, we use a recognized tool for job evaluation, salary mapping, and salary setting. Nordic Biomarker is covered by the collective agreement between IKEM, Unionen, Swedish Engineers/Scientists and Managers, which means that salary setting is individual and differentiated. This means, among other things, that the final salary is set taking into account the applicant's previous work experience and competence. For this position, the starting salary is between 37,000–47,000 kr per month. About Us Nordic Biomarker is a leading manufacturer and supplier of advanced reagents and control materials for coagulation analysis. The headquarters is located in Umeå, but research and development as well as manufacturing are conducted at the company's two sites, Umeå and Linköping. We offer both CE-marked kits under the Medirox brand as well as customized solutions for companies that want to use our products under their own brand. With us, you get to work in an environment where your work truly makes a difference – for our products, our customers, and ultimately the patients. We value curiosity, commitment, and an unpretentious working style where everyone contributes and supports each other regardless of the scope of the task.Now we are looking for an R&D Engineer at Nordic Biomarker with a focus on CE marking according to IVDR! Do you want to be part of developing future solutions in coagulation diagnostics – from idea to finished product, while also contributing to ensuring that our products meet the high requirements of IVDR? With the world as our market, Nordic Biomarker is a small large company within Life Science that develops, manufactures, and sells quality products for coagulation diagnostics all under one roof. You are welcome to a workplace characterized by family spirit, good collaboration, engaged…

Overview

Type

job

Status

active

Visibility

public

Price

37 000 SEK /month

City

UMEÅ

Address

Vildmannavägen 1

GPS

63.837245584831, 20.263799659664copyopen in

Email

Show email

Views

4

Published

1. 7. 2026

Edited

30. 7. 2026

Specifications