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.
Job Summary
The Senior Product Development Technician is responsible for supporting the Product Development team to develop balloons, catheters and processes for projects under development through the PRP process. The Senior Technician will support development projects through the entire design cycle and commercial supply. This role is based in our facility in Ballinasloe, Co. Galway and offers a 4 day condensed working week, inclusive of Monday to Thursday. One year fixed term Temporary contract.
Responsibilities
* Build prototype and validation/verification product and complete process development on relevant processes.
* Support the engineers in the development of products.
* Act as a technical lead to process and equipment during development of products.
* Responsible for troubleshooting machine downtime and basic maintenance.
* Generate test data and technical documentation to support ongoing product design / development.
* Troubleshoot technical design / process / equipment issues and implement changes through change control procedures.
* Ensure area of responsibility meets regulatory compliance and is audit ready at all times in terms of GMP and GDP.
* Provide daily support with equipment/process set ups and development of catheter/balloon processes and products.
* Understanding of applicable regulations including ISO and FDA regulations.
* Provide input during design reviews in relation to process and product development activities.
* Complete documentation updates to support new work instructions & updates to existing documentation.
* Take part in meetings to discuss projects on weekly basis.
* Support introduction of new technologies / equipment.
* Support / train operators to build and test catheters/balloons or sub-assemblies during the PRP process.
* Provide coaching to technicians and operators to drive engagement in continuous improvement for process / equipment during the PRP process.
Experience and Qualifications
* Minimum 3 years' experience in a medical device or other regulated industry.
* Diploma (Level 7) or equivalent relevant qualification/experience.
Competencies and Attributes
* Must have strong technical ability and be self-motivated.
* Ability to problem solve design and process related issues is essential.
* A good knowledge of catheter and balloon manufacturing processes.
* Ability to trial and implement device design and process improvements with direction from the Product Development Engineers.
* Works closely with Product Development Engineers while applying his/her own initiative in most situations.
* Committed to continuous learning and development.
* A good team player who works well in a small team environment.
* Good interpersonal skills while building effective relationships with employees in other departments.
* Attention to detail while maintaining awareness of short/mid-term objectives.
* Strong computer skills with good written communication skills.
Surmodics offers a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension with employer match.
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.