- Reference: GJ445667
- Job Type: Permanent
- Location: Galway, Galway City, Mayo
- Category: Medical Devices
As a member of a small R&D team, you will have the responsibility for developing, optimizing and maintaining manufacturing processes, supporting both product development and manufacturing needs.
Essential job duties and responsibilities:
Employees are expected to support the quality concepts inherent in the business philosophies of our client including a variety of job related tasks, which may not be specific to this position profile.
- Process Development
a. Lead process development activities in assigned area, supporting the needs of new product developments, manufacturing and continuous improvement initiatives
b.Develop manufacturing processes from conception to full scale production, ensuring a smooth transfer from design to production.
c. Introduce new manufacturing methodologies and technologies to support and optimize product development
d.Lead the process validation activities e.g. IQ, OQ, PQ and PPQ.
- Product Development
a. Review product designs, test protocols and co-develop critical characteristics/tolerances for initial testing, validations and subsequent routine manufacturing controls.
b.Participate in design evaluations where appropriate.
c. Support product development builds including prototype and pre-production build
- Continuous Improvement Support
a. Lead and support design and process improvement activities.
b.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.
- Manufacturing and Lab Equipment Support
a. 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.
b.Maintain the R&D equipment and laboratories in line with GMP to support all R&D prototyping activities and pre-design verification builds.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
- Minimum of Bachelor’s degree in engineering or material Science.
- Minimum of 8 years of experience preferably in the medical device industries or other comparable industries (e.g. electronics, automotive etc.)
- Qualification in 6 sigma or an equivalent accreditation.
SKILLS AND KNOWLEDGE:
- Knowledge of engineering theories, methods and work measurement techniques.
- Ability to apply engineering methods in the definition, design, research, development, utilisation, maintenance, and cost-control of processes and equipment to build our client Medical products, improve qualities and reduce costs of such processes and products.
- Ability to communicate and work with people inside and outside the department as necessary to execute these responsibilities.
- Ability to understand and follow appropriate department policies, procedures, practices and to understand inter-relationships of people and functions.
- Knowledge of techniques and tools for improving manufacturing products and processes is an advantage 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.
- Primarily work in a sitting position.
- Occasional must be able to carry up to 10 lbs and lift up to 24 lbs.
- Complete Plant Mobility
- Result driven
- Attention to detail.
- Good team worker
- Good analytical and problem solving