Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.
We are looking for a Senior R&D Engineer to join us in our mission. This role is based in our facility in our Ballinasloe, Co.Galway and the working week is a 4 day compressed week from Monday to Thursday. Role is onsite but there are opportunities for flexible working arrangements
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.
- 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
We offer competitive rewards & compensation to meet the needs of our employees, and this includes:
- Competitive Salary Package
- 4 day working week
- Equity/Stock Options award
- Annual Bonus Plan
- Pension Plan
- Medical Insurance & Life assurance cover
- Employee Share Purchase Scheme
- Career advancement opportunities
Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sexual orientation, gender identity, national origin, disability, civil status or members of traveller communities.