Senior R&D Engineer
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
Please apply via the button on the right side of this job offer.
Job details
Location: Wrocław
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
Location: Wrocław
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
More
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