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About
Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.
- Design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner.
- Product testing and evaluation, completion of test reports to support design selection.
- Preparation and presentation of design reviews.
- Product risk analysis and risk management.
- Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques.
- Source new materials components and equipment.
- Development of component specifications, inspection methods, bills of materials and manufacturing processes.
- Introduction of new equipment, materials and technologies.
- As required work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices to improve patient care.
- Work closely with Project Lead and take responsibility for assigned research and development project tasks:
- Manage and drive assigned project tasks to ensure timely completion of project milestones.
- Work closely with cross functional groups to achieve project and company goals.
- Product performance evaluations.
- Contribute to innovation and creativity within team through filing of disclosures and patents.
- Hold regular project meetings and document minutes and actions.
- Ensure project milestones are achieved to meet business metrics.
- Communications:
- Regular communication to cross-functional teams and senior management.
- Project status communications and reporting.
- Remain on the forefront of emerging industry practices.
- Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products.
- Support other cross functional groups to deliver company goals.
Qualifications
- Bachelor’s degree is required, preferably in engineering or a related field.
- Minimum of 3 years’ relevant experience is desired.
- Project planning/execution skills.
- Execution of project in a timely effective manner.
- Knowledge of anatomy and physiology.
- Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge.
- Statistical understanding and experience.
- Manufacturing design and process understanding.
- Good working knowledge of Solidworks and/or Pro Engineer CAD.
- Strong technical writer. xcfaprz
- Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
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Languages
- English
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