Senior R&d Engineer

Senior R&D EngineerNumer ref.: JN -112021-4532973

Perfect opportunity to launch new R&D office & new team in Wrocław - our Client is looking for a Senior Engineer with experience gained in In Vitro Diagnostics / Life Sciences / medical devices industry!

Client Details

Our Client is a start-up in the Life Sciences industry, which aims to develop and manufacture an In Vitro Diagnostic device for global markets, in constant collaboration with a UK Company. Our Client's objective is to complete the R&D project within two years and begin manufacturing in year three, systematically increasing Polish R&D Team.

 

Description

• Responsibility for whole R&D project connected with transforming a functioning prototype design into a production series instrumentation units for global export markets
• Develop the required compliance and regulatory documentation through Alpha and Beta stages of development
• Increase manufacturability and serviceability
• Identify and select the preferred supply-chain entry route: develop the instrument with a supply-chain fully mapped out and costed according to unit cost price expectations and value-engineering objectives
• Leads, designs and/or develops the technical specification identifying and ensuring robust system architectures that are scalable, manufacturable and serviceable
• Applies system and value engineering principles to develop cost-effective, reliable, high-quality system functions that satisfy product specifications, compliance, customer needs and business needs
• Support the development of product specifications and tolerances, product and technical requirements, design and process FMEAs for the Device Bill of Materials
• Perform capability testing on essential component parts with the use of statistical data analysis and durability testing
• Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes

Profile

• Higher technical education (at least Bachelor degree) in Mechanical Engineering; Masters or PhD degree desirable
• Minimum 5 years of professional, complex experience in the design and development of scientific / analytical / medical / In Vitro Diagnostic devices or similar advanced devices
• Expertise and experience in mechanical engineering plus general knowledge of electronic engineering
• Fluent English (at least B2/C1 level)
• Capability to learn quickly, to take responsibility for whole R&D project (as well as to make use of own network of supplier & engineering companies that can help facilitate the project)
• Specific training and demonstrated success in applying quality problem solving methods such as: fishbone diagrams, Root Cause-Corrective Action (RCCA), FMEA, process capability analysis, hypothesis testing
• Preferably, experience in an FDA/CE regulated environment with ISO mark experience
• Being passionate about innovation, hands-on approach

Job Offer

• Opportunity to expand and prove one's skills in a new R&D start-up with global export ambitions - holding the position of 1st employee hired in Polish office
• Attractive salary & other employment conditions (including B2B contract)
• Opportunity to further develop as a team leader in the future