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.
