Responsibilities
Perform Duties of Senior Research & Development Engineer:
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.
Product and project risk analysis and risk management.
Develop prototypes which are consistent with the clinical and design requirements of the project.
Research new therapies and design solutions to develop and complement the existing product portfolio.
Introduce new equipment, materials and technologies.
Work closely with Key Opinion Leaders (KOL's), 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.
Lead technical development of projects.
Lead all key design decisions to ensure quality design selection.
Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved.
Work closely to build effective relationships with cross functional groups to achieve project and company goals.
Retrospective project reviews to understand lessons learned.
Manage device evaluations.
Compliance with Quality, Regulatory and company policies and systems.
Mentoring, coaching and development of direct reports if required.
Foster innovation and creativity within team and perform disclosure reviews.
Compliance with Quality, Regulatory and company policies and systems.
Communications:
Regular communication to cross-functional teams, senior management and business unit leaders.
Project status communications and reporting.
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.
Qualifications
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 (ISO***** 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 commercialization.
Ability to effectively translate needs of clinicians and SBU into project inputs.
Willingness and availability to travel on company business.
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