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Our initial technology platform is a catheter-based device used to treat the build-up of fluid in the body resulting from late-stage cancer.
Role: As a Senior R&D Engineer you will get the opportunity to apply your engineering knowledge in areas such as test method development and validation, design controls, useability, risk management and pre-clinical testing during this exciting time as they bring their products to market.
My client are a high paced start-up moving from Phase 2 to Phase 4 within the next 18 months working closely with our Contract Manufacturer.
Responsibilities:
- Supporting design/development of our product including concept development, HFE, design feasibility, prototype development, detailed design and DFM, risk management, and design verification/validation activities.
- Participating in test method development and test method validation.
- Engaging with vendors and suppliers on a regular basis to ensure efficient delivery of services.
- Preparation of technical documentation in accordance with regulatory and design control requirements and with the company's development processes.
Including part and material specifications, technical drawings engineering and clinical/HFE protocols/reports for support of FDA and EU MDR submission.
- Facilitate problem-solving efforts by coordinating initiatives to identify root causes and implement effective solutions.
Perform advanced data analysis and generate comprehensive reports that document findings, draw conclusions, and provide actionable recommendations.
Requirements:
- Minimum Bachelors degree in science, engineering, or related field or equivalent.
- Minimum of 4 years in a similar role in medical device R&D or equivalent.
- Experience working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
- Experience in medical device design and development principles, material selection, design validation and test method development essential. xcfaprz
Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on OR Skills: R&D Validation Engineer Benefits: Bonus of 10%
Languages
- English
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