Design Assurance Engineer

<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p> <p>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.</p> <p>We are looking for a Design Assurance Engineer<strong> </strong>to join us in our mission. <strong>T</strong><strong>his 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. </strong></p> <p><strong><u>Job Summary</u></strong></p> <p>The Design Assurance Engineer will be deeply involved in all stages of the new product development cycle and sustaining engineering projects after commercialisation.  The role offers the opportunity to be part of a cross functional team that influences product excellence in a highly innovative and dynamic environment.  The Design Assurance Engineer will guide the team through design controls, risk management, verification and validation, and compliance.     </p> <p><strong><u>Responsibilities </u></strong></p> <ul> <li>Support the delivery of cutting-edge, innovative products to market by providing quality and regulatory guidance to cross-functional project teams.</li> <li>Contribute to the development and execution of design assurance activities, including design plans, protocols, and reports for new product development and design/process changes.</li> <li>Collaborate with R&D and Process Engineering teams to enable a smooth transition from development through product approval to manufacturing scale-up.</li> <li>Assist in defining and implementing quality standards and specifications, supporting continuous improvement in product and process quality.</li> <li>Ensure compliance with applicable regulatory standards and customer requirements, including ISO 13485, across all design and development activities.</li> <li>Contribute to post-market activities, including Customer Complaints and Post-Market Surveillance, to support ongoing product quality and compliance</li> <li>Support validation activities, including execution of equipment, process, and product validations in line with regulatory requirements.</li> <li>Analyse test results and process data, contributing to sound technical conclusions and effective decision-making within the team.</li> <li>Support achievement of project timelines, particularly in relation to quality deliverables and regulatory submissions.</li> <li>Promote the effective use and adoption of the Quality Management System (QMS) within project teams.</li> <li>Participate in audit activities, supporting preparation, execution, and closure of audit findings through appropriate corrective and preventive actions (CAPA).</li> </ul> <p><strong> </strong><strong><u>Experience and Qualifications</u></strong></p> <ul> <li>An Engineering or Quality Assurance Degree or equivalent experience.</li> <li>3 - 5 years post qualification experience as a Design Assurance Engineer within a Medical Device or regulated environment.</li> </ul> <p><strong><u>Competencies and Attributes</u></strong></p> <ul> <li>Strong working knowledge of the product development process within the medical device industry.</li> <li>Detailed knowledge of the regulatory environment in which the business operates including FDA, European, and other International Regulatory requirements.</li> <li>Ability to support and lead DA activities on multiple projects simultaneously.</li> <li>Strong technical writing and verbal communication skills.</li> <li>A good team player who works effectively both on their own and with peers from cross functional team members.</li> <li>Strong interpersonal / communication skills, with ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.</li> <li>An analytical approach to problem solving.</li> <li>Is creative, continually learning and exploring new ideas.</li> <li>A self-starter who applies his/her own initiative in most situations.</li> <li>Capacity to make sound judgements while learning from mistakes.</li> <li>Attention to detail while maintaining awareness of longer-term objectives.</li> <li>Displays the highest levels of integrity.</li> <li>Capacity to maintain the highest levels of confidentiality internally and externally.</li> </ul> <p>Surmodics offers a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension with employer match, medical insurance. Life assurance cover, Recognition Awards. </p> <p>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.</p>