PRODUCT DEVELOPMENT ENGINEER
Title: Product Development Engineer
Type: Permanent full time
Required experience: Minimum 2 Years
My client based in Limerick is currently recruiting for a NPD Engineer to design, development and taking to market of medical devices for one or more client's Strategic Business Units
- 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 effective manner.
- Product testing and evaluation, completion of test reports to support design selection
- Preparation and presentation of design reviews
- Product and project risk analysis and risk management.
- Work with Manufacturing Engineering to introduce new equipment and production processes as required for any new manufacturing techniques.
- Source new materials components and equipment.
- Development of component specifications, inspection methods, bills of materials and manufacturing processes.
- Introduction of new equipment, materials and technologies.
- Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.
- Project lead for assigned product development projects including technical and project management responsibly.
- Manage and drive project tasks to ensure timely completion of project milestones.
- Work closely with cross functional groups to achieve project and company goals.
- Product performance evaluations.
- Contribute to innovation and creativity within team through filing of disclosures and patents.
- Hold regular project meetings and document minutes and actions.
- Ensure project milestones are achieved to meet business metrics
- Compliance with Quality, Regulatory and company policies and systems.
- Full job spec available on request
- 3rd level degree in Mechanical, Biomedical, Design, Chemical Engineering or similar discipline
- 2 Years design experience medical device roles.
- Project planning skills.
- Execution of project in a timely effective manner
- Knowledge of anatomy and physiology.
- Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
- Manufacturing design and process understanding
- Good working knowledge of Solidworks and/or Pro Engineer CAD.
- Strong technical writer.
- 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.