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 R&D Engineer II 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.
The R&D Engineer II 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 Products and corresponding processes which meet the customer requirements throughout the design phase.
- May act as a technical lead on a project
- Generate technical documentation for the Product Design History File and Device Master Records.
- Develop test methods for product evaluation and validation. Develop and execute test method 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.
- Experience within a Medical Device environment with 3-5 years spent in the R&D Dept.
Competencies and Attributes
- Demonstrable detailed working knowledge of the medical device industry.
- A good knowledge of design life cycles requirements.
- Track record of successful impact on projects
- An analytical approach to problem solving.
- Is creative, continually learning and exploring new ideas. May be a technical authority on certain aspects of a project
- A self-starter who proactively enacts change, applies his/her own initiative in most situations and drives continuous improvement.
- 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.
Surmodics offers a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension with employer match, employee stock purchase plan and stock options.
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.