Our client, a medical device company in Galway is currently looking to recruit a Senior R&D Engineer – Process Development for their site.
The Senior R&D Engineer directs, coordinates, and exercises functional authority for planning, organization, control, integration and completion of engineering activities within area of assigned responsibility and focusing in Process Development. The associate is an advanced individual contributor using professional concepts and company objectives to resolve complex issues in creative and effective ways.
Essential Job Duties And Responsibilities:
Employees are expected to support the quality concepts inherent in the business philosophies, including a variety of job related tasks, which may not be specific to this position profile.
- Lead process development activities in assigned area, supporting the needs of new product developments, manufacturing and continuous improvement initiatives
- Develop manufacturing processes from conception to full scale production, ensuring a smooth transfer from design to production.
- Investigates, research and develops and implements new process technologies.
- Introduce new manufacturing methodologies and technologies to support and optimize product development
- Lead the process validation activities e.g. IQ, OQ, PQ and PPQ.
- Review product designs, test protocols and co-develop critical characteristics/tolerances for initial testing, validations and subsequent routine manufacturing controls.
- Participate in design evaluations where appropriate.
- Support product development builds including prototype and pre-production build
- Lead and support design and process improvement activities.
- Act as an advocate for continuous improvement activities using statistical techniques, lean manufacturing tools, six sigma, design experimentation for process and equipment, to achieve targets and cost savings.
- Lead troubleshooting on equipment while providing coaching and mentoring to other engineering staff. Will have prime role with respect to equipment and process safety ensuring standards are met and exceeded at all times.
- Maintain the R&D equipment and laboratories in line with GMP to support all R&D prototyping activities and pre-design verification builds.
- Minimum of Bachelor’s degree in Engineering or Material Science.
- 5-10 years’ experience in a similar manufacturing environment.
- Functional knowledge: requires depth or specialized expertise in own discipline or broad expertise in multiple disciplines to serve as the internal expert.
- Business acumen: anticipates business challenges to proactively champion changes to strategy.
- Leadership: leads project team with notable risk and complexity, develops and implements the strategy for project execution.
- Problem solving: drive the development of innovative solutions to solve unique and complex problems with broad impact on the business.
- Impact: impacts strategy, direction and resource allocation to achieve business results.
- Communication & interaction: communicates complex ideas, anticipates potential objections and persuades others, often senior leadership, to adopt a different point of view.
- Knowledge of engineering theories, methods and work measurement techniques.
- In-depth knowledge of guidewires or catheters technologies and manufacturing processes is an advantage.
- Knowledge of techniques and tools for improving manufacturing products and processes is paramount e.g. Doe, statistical techniques, sampling size, six sigma, minitab etc…
- Proficiency and experience in 2D and 3D CAD Modelling using Solidworks or equivalent is an advantage.
- Occasional must be able to carry up to 10 lbs and lift up to 24 lbs.
For further information on this Senior R&D Engineer – Process Development role in Galway please contact Deirdre Finnerty on 086 3073779 / firstname.lastname@example.org
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