Systems Engineer

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.

We are looking for a Systems Engineer who wants to make an impact and change the world of ventilation for the better.

At Breas Medical, you will get the chance to work on projects of high importance that improve our end users quality of life. Working at Breas Medical will most likely be a new, impactful chapter of your life, and be a great opportunity for growth.

As one of our key talents, you will be joining at a very exciting stage of our journey. We have just launched two new product series within our Vivo range, with a total of seven new ventilator products. These new products enable us in our strive to be our customers preferred choice and the global market leader within the mechanical ventilator product segment.

Responsibilities:

• Expertise in the development, testing and manufacture of medical device
• Develop solutions to a variety of technical problems of varying complexity, perform in a team environment and work under the direction of a group lead.
• Ability to invent, think creatively, and be resourceful
• Provide guidance for support equipment, operations, disassembly, assembly, discrepancy identification, maintenance and repair.
• Provide technical guidance during the isolation and correction of discrepant conditions, equipment defects, and procedural difficulties encountered on production
• Apply Electrical Engineering principles, theories and concepts.
• Electronics lab experience including oscilloscopes, volt-ohm meters, soldering skills, etc.
• Researches and analyzes information such as customer requirements, standards, and industry trends to determine feasibility of design or application.
• Designs, develops, analyzes and documents product designs in accordance with ISO, FDA and corporate design control guidelines
• Coordinate and lead a cross-functional team from prototype stage through pilot manufacturing including manufacturing process validation.
• Knowledgeable in state of the art manufacturing processes (plastics, 3-D printing, etc)
• Perform and report on evaluation testing, verification and validation in accordance with ISO, FDA and company design control guidelines.
• Knowledgeable on design for reliability, testability and manufacturability
• Accurately predict the time required for project tasks; help assure the scheduled time is met or improved to meet company objectives.
• Fabricates special-purpose jigs, fixtures, and adapters

Requirements:

• BS degree in an engineering discipline, mathematics, computer science, or other degree with focus on science, engineering, and quantitative analysis
• 2+ Years of experience in product and Systems validation and testing
• Experience with requirements and data analysis in a product development environment
• Knowledge with quantitative software preferred, MATLAB, Minitab or similar
• Advanced user of Excel (Visual Basic scripting abilities is a plus)
• Excellent oral and written communication skills
• Knowledge of ISO, FDA, GMP and design control process is required

Knowledge of IEC standards and testing. Demonstrated knowledge of Product Design for Assembly (DFA).