Design Change Engineer and Label Design

When you can´t breathe, nothing else matters

Our vision at Breas is to provide innovative solutions that enable people with chronic respiratory conditions to live life to the fullest.

Are you an engineer, who wants to make an impact and change the world of ventilation for the better? Then we have the place for you.

At Breas Medical you will have the chance to work on projects of high importance that improves the quality of life of our end users. Working at Breas Medical will most likely be a new impactful chapter of your life and be a great opportunity for growth. You will be joining Breas at a very exciting stage of our journey. We have recently launched two new product series within our Vivo range, with a total of seven new ventilator products on the market. These new products enable us in our strive to be the preferred choice of our customers and the global market leader within the mechanical ventilator product segment.

This position is based at the Breas global headquarter in Mölnlycke, Sweden. Breas Medical is owned by Fosun Pharmaceutical (Group).

About the role

The role is twofold: Design Changes and Label Design:

• As a Design Change Engineer you will work with updates of Breas existing products and accessories.
• As a Label Design responsible you will make sure that Breas products are correctly and properly labelled.

You will be responsible for planning, coordinating and follow-up of changes to product design. You will work cross-functionally within Engineering as well as other departments as Marketing, QA/RA and Operations.

Breas has a wide range of products and accessories. Working with design changes during the life cycle of the products includes everything from smaller bug fixes and documentation updates to adding new features and developing new accessories. As the Breas products are medical devices there are several activities to fulfill regulations in the many markets where the products are sold. The Design Change Engineer is responsible for making sure all those activities are done when a change is made to a product. You will both lead design changes yourself and help others with design change projects.

The information on the label is an important part of the complete product design. There are several standards and regulations for medical products that affects the content of the labels. Your responsibility will be to create needed labels and design the content to fulfill applicable regulations.

What will you do

• Plan, coordinate and perform design change activities for Breas products according to the Breas Engineering Change procedure
• Support Engineers in acting as Change Owners for design changes
• Participate in the Engineering Change Control Board to review all design changes made on Breas products
• Design labels for Breas products and ensure compliance with the relevant standards.

Your background & experiences

• Academic background in Engineering (Bachelor or Master’s degree) or corresponding experience
• Knowledge of the medical device industry and relevant standards (e.g. ISO 13485, IEC 60601, MDR)
• Experience working with Adobe Illustrator and/or other graphic design programs is considered a merit

About you

You like to take responsibility for your own tasks, competences and beyond. You are analytical and structured with the ability to work cross-functionally. You have project and teamwork experience and high communication and documentation skills. Speaking & writing fluently in both Swedish and English is a must. We speak Swedish in the office but the company language is English.

About Breas Medical

Our focus is first and foremost on the patients and customers we serve. Breas Medical was founded in 1991 in Gothenburg, Sweden, and has become one of the global leaders in Home Mechanical Ventilation, Airway Clearance and Sleep therapy. Our vision is to provide better breathing and quality of life to respiratory patients around the world and to help patients transition from Hospital to Home.

Breas is headquartered in Sweden and has subsidiaries in the UK, Germany, Spain, USA and China. Breas has approximately 250 employees. Together with a network of highly specialized distributors, we serve over 40 countries worldwide. The Breas brands Vivo, Nippy, Clearway and Z1 are widely recognized and appreciated for their performance, design and ease of use.

We highly value our relationships, never compromise on quality, continuously improve customer support and expand our clinical excellence program that consists of study days, webinars, educational videos, symposia and clinical research. We work closely together with key opinion leaders around the world to stay updated on the latest clinical insights. All Breas products are designed to fulfil our vision and to help patients transition from Hospital to Home. We strive to become a total solution provider offering a broad range of products, from smart CPAPs to Bi-levels, NIV ventilators, Life-Support ventilators and Airway Clearance devices. Add to that a growing range of accessories and remote connectivity solutions.

Find out more about Breas:
educationbybreas.com, breas.com or check out our channel on Twitter, LinkedIn or Facebook.