Senior R&D Engineer
The Senior R&D Engineer works as parts of the R&D team tasked with the development of new medical device products in compliance with applicable regulations including EU and FDA regulations. 4 day, compressed working week.
Develop manufacturing processes and corresponding products which meet the customer requirements.
Generate technical documentation for the Product Design History File and Device Master Records.
Develop protocols and execute process validations.
Liaise where necessary with Business Development and Physicians to understand and validate the specific market requirements in any given product segment.
Partner with Manufacturing Engineering, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
Support Manufacturing post product commercialization.
As part of the R&D team, contribute effectively to the broader technical and resource needs of the team while ensuring specific technical expertise is continually developed and strengthened
An Engineering or Science Degree.
A minimum of 5 years post qualification experience within a Medical Device environment with at least three spent in process development.
Competencies and Attributes
Demonstrable detailed working knowledge of the medical device industry.
A good knowledge of design life cycles requirements.
An analytical approach to problem solving.
Is creative, continually learning and exploring new ideas.
A self-starter who applies his/her own initiative in most situations.
A good team player who works well in a small team environment.
A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation.
Capacity to make sound judgements while learning from mistakes.
Good understanding and application of project management tools.
Effective knowledge of the regulatory environment in which the business operates.
Attention to detail while maintaining awareness of longer-term objectives.
Strong interpersonal skills, a demonstrated ability to influence his/her peers.
Displays the highest levels of integrity.
Capacity to maintain the highest levels of confidentiality internally and externally
Any applicant must have an existing valid work permit/ visa to apply. (Stamp 4 or EU passport).
Reach out to firstname.lastname@example.org or 087-189 7333 for more details.