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Job ID: JOB-12424

Lead Research & Development team in the design, development and taking to market of medical devices for Vascular

Position:                      Senior Research & Development Engineer    

Reporting to:              Research & Development Manager   

Responsibilities:

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• Perform Duties of Senior Research & Development Engineer:
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  • 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.
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  • Product and project risk analysis and risk management.
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  • Develop prototypes which are consistent with the clinical and design requirements of the project.
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  • Research new therapies and design solutions to develop and complement the existing product portfolio.
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  • Introduce new equipment, materials and technologies.
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• Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.
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• Project lead for assigned Research & Development team/s including technical and project management leadership responsibly.
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  • Lead technical development of projects.
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  • Lead all key design decisions to ensure quality design selection.
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  • Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved.
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  • Work closely to build effective relationships with cross functional groups to achieve project and company goals.
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  • Retrospective project reviews to understand lessons learned.
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  • Manage device evaluations.
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  • Compliance with Quality, Regulatory and company policies and systems.
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• Mentoring, coaching and development of direct reports if required.
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  • Foster innovation and creativity within team and perform disclosure reviews.
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  • Compliance with Quality, Regulatory and company policies and systems.
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• Communications:
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  • Regular communication to cross-functional teams, senior management and business unit leaders.
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  • Project status communications and reporting.
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  • Ensure effective reporting to the R&D Manager
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• Remain on the forefront of emerging industry practices.
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• Instrumental in driving and implementing change to improve departmental and company performance.
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• 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.
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• Support other cross functional groups to deliver company goals.
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• Act as a designee of the Research & Development Manager and the Senior Test Engineer.
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• Ensure that the Company’s Code of Conduct is considered in all business matters carried out on the Company’s behalf.
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Qualifications / Requirements:

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• Third level degree in Mechanical, Biomedical or similar discipline, Masters or Ph.D. level preferred but not essential.
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• 7+ years’ experience is ideal.
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• Proven Project Leadership abilities.
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• Good Project Management methodology and skills.
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• Proven track record in delivering quality results in a timely effective manner.
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• Knowledge of anatomy and physiology.
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• Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
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• Innovative/Creative Engineer.
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• Good manufacturing design and process understanding.
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• Good working knowledge of Solidworks and/or Pro Engineer CAD.
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• Good presentation skills (working knowledge of MS PowerPoint).
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• Strong technical writer.
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• Attention to detail and Quality focus.
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• Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820).
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• Team Player with ability to develop strong working relationships.
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• Strong communication and inter-personal skills.
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• Good problem solving skills.
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• Highly motivated individual, self-starter with a passion for excellence.
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• Must be able to work in a fast paced environment.
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• Ability to foster relationships with key stakeholders required to ensure on time project delivery.
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• Experience of medical device development from concept through to commercialisation.
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• Ability to effectively translate needs of clinicians and SBU into project inputs.
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• Willingness and availability to travel on company business.
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Johanne Kennedy

JOB-12424

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