Senior Research & Development Engineer
Hybrid - 2/3 Days WFH
- Perform Duties of Senior Research & Development Engineer: o 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 and effective manner. o Product and project risk analysis and risk management. o Develop prototypes which are consistent with the clinical and design requirements of the project. o Research new therapies and design solutions to develop and complement the existing product portfolio. o Introduce new equipment, materials and technologies.
- Work closely with Key Opinion Leaders (KOLs), physicians and product managers to develop innovative medical devices to improve patient care.
- Project lead for assigned Research & Development team/s including technical and project management leadership responsibly. o Lead technical development of projects. o Lead all key design decisions to ensure quality design selection. o Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved. o Work closely to build effective relationships with cross functional groups to achieve project and company goals. o Retrospective project reviews to understand lessons learned. o Manage device evaluations. o Compliance with Quality, Regulatory and company policies and systems.
- Mentoring, coaching and development of direct reports if required. o Foster innovation and creativity within team and perform disclosure reviews. o Compliance with Quality, Regulatory and company policies and systems.
- Communications: o Regular communication to cross-functional teams, senior management and business unit leaders. o Project status communications and reporting. o Ensure effective reporting to the R&D Manager or Senior R&D Manager.
- Remain on the forefront of emerging industry practices.
- Instrumental in driving and implementing change to improve departmental and company performance.
- 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.
- Act as a designee of the Research & Development Manager orr the Senior Test Engineer if required.
- Ensure that Cooks Code of Conduct is considered in all business matters carried out on Cooks behalf.
Qualifications / Requirements:
- Third level degree in Mechanical, Biomedical, Science, Design or similar discipline, Masters or Ph.D. level preferred but not essential.
- 5+ years experience is ideal.
- Proven Project Leadership abilities.
- Good Project Management methodology and skills.
- Proven track record in delivering quality results in a timely effective manner.
- Knowledge of anatomy and physiology.
- Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
- Innovative/Creative Engineer.
- Good manufacturing design and process understanding.
- Good working knowledge of Solidworks and/or Pro Engineer CAD.
- Good presentation skills (working knowledge of MS PowerPoint).
- Strong technical writer.
- Attention to detail and Quality focus.
- Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820).
- Team Player with ability to develop strong working relationships.
- Strong communication and inter-personal skills.
- Good problem solving skills.
- Highly motivated individual, self-starter with a passion for excellence.
- Must be able to work in a fast paced environment.
- Ability to foster relationships with key stakeholders required to ensure on time project delivery.
- Experience of medical device development from concept through to commercialisation.
- Ability to effectively translate needs of clinicians and SBU into project inputs.
- Willingness and availability to travel on company business.
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- Rev 3, Last Reviewed: 01 July 2022
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