Senior Result

1 week ago

Limerick, Limerick, Ireland Oxford Global Resources Full time

Are you a Senior Result & Development Engineer looking for a new opportunity? Are you interested in cultivating unique, quality products improving lives? Don't hesitate, and apply today Job Description The senior result & development engineer will lead a Research & Development team in the design, development and taking to market of medical devices. Qualifications / Requirements: Third level degree in Mechanical, Bio-medical, 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. Responsibilities: Minimum 12 years relevant professional experience with at least 7 years of project management experience within the biologic pharmaceutical industry in manufacturing, CMC or R&D Bachelor's degree (Required); Advanced degree preferred - area of study: science (biology, chemistry, etc.) or management (MBA) preferred Demonstrated ability to clearly and concisely communicate/present key information to senior management Demonstrated ability to build consensus and drive resolution of issues while maintaining positive working relationships across functions Capable of balancing and managing multiple projects, each with varying priorities, time-lines, and resources Understanding of bio-manufacturing processes and technologies, including GMP requirements and systems as well as tech transfer, process improvements and issue resolution Experience working with 3rd parties from due diligence through partner management Ability to assess business needs and apply process and systems-based solutions Ability to work across geographic areas with sensitivity to cultural differences Ability to establish and articulate processes which impact cross-functionally Ability to recognize problems before they occur, to appropriately raise issues to management, to bring an insightful approach to problem solving, and to communicate issues to stakeholders in a mature, professional manner Strategic thinking - ability to approach specific issues/problems with understanding of the larger context Strong communication skills - written and verbal ability to present information in a clear and concise manner Strong organizational skills Negotiation and strong persuasive abilities Management skills - ability to handle a variety of diverse tasks simultaneously while achieving deadlines Demonstrate a high degree of self-awareness, self-motivation, initiative, and attention to detail Proficiency using Microsoft Word, Excel, PowerPoint, Project, and SharePoint Project Management Professional (PMP) certification with PMI desired.

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