The primary responsibility of the R&D Engineer II is to support and lead on the design, development and taking to market of medical devices.
Responsibilities :
- Perform Duties of Research & Development Engineer 2 :
- 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 toward s p rocess d evelopmen t during introduc tion /develop ment 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 w ork closely with Key Opinion Leaders, physicians , product managers and team to develop innovative medical devices to improve patient care.
- Work closely with Project L ead 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.
- Ensure that the company’s Code of Conduct is considered in all business matters carried out on the company’s behalf.
Requirements :
- 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.
- Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
- Willingness and availability to travel on company business.
