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Principal Product Development & Manufacturing Engineer

SymPhysis Medical
Galway, IrelandOn siteYesterday

Job description

Who are we? SymPhysis Medical are an emerging company focused on developing patient solutions in the area of palliative care. Our initial technology platform is a catheter-based device used to treat the build-up of fluid in the body as a result of late-stage cancers. Over the past 7 years, our Team, who are passionate about developing patient-centred products, have built strong and lasting relationships with partners that have helped fast-track the development of our disruptive releaze® device. As a result of this success and momentum, we are hiring a Principal Product Development & Manufacturing Engineer to join our Team based in Galway. The Opportunity As a Principal Product Development & Manufacturing Engineer, you will get the opportunity to apply your knowledge in areas such as, Manufacturing and Supplier Management, Product Development, Design Control Support and DV Support during this exciting time at Symphysis Medical, as we bring our products to market. We are a high-paced emerging company working towards FDA submission, working closely with our Contract Manufacturers. The Successful Person will be responsible for areas such as: Product Development & Design Control Leadership - Lead the development and maintenance of design control documentation (e.g., design history files, specifications, drawings). - Provide guidance on change management processes (deviations, design changes). - Support cross-functional teams in design reviews and risk management activities. - Support lifecycle management activities, including design updates and cost/quality improvements. Manufacturing Support - Act as the primary R&D interface to manufacturing - Lead manufacturing reviews and ensure design for manufacturability principles are applied - Lead OQ and PQ activities - Investigate and resolve manufacturing issues - Ownership of build trackers and ensure alignment between development builds and production readiness - Provide technical oversight of key suppliers in collaboration with the Quality department - Support supplier selection, qualification, and performance monitoring. - Act as escalation point for complex supplier-related technical issues What experience do you need? - Bachelor's or Master's degree in Engineering (Mechanical, Biomedical, or related discipline) - Significant experience in medical device product development complying with ISO 13485, EU and US medical device regulations - Proven experience supporting manufacturing and working with external suppliers - Strong knowledge of design control, risk management, and change control processes - Expertise in manufacturing processes and design for manufacturability (DFM) - Excellent problem-solving and root cause analysis skills - Strong stakeholder management and communication skills - Proven experience in management of multiple projects with excellent knowledge of project management tools and principles Our Vision & Goal Our vision is to provide ‘ Independence through Innovation ' for people requiring palliative care and to build a scalable Irish business focusing on providing quality of life. With our core clinical ties in Ireland, we are also working with some of the top cancer centres in the US. Our global ambition is to expand into multiple therapeutic areas where we can apply our technology to improve patients' quality of life, reduce hospital costs and help enable patient independence. By working closely with our clinical, academic and manufacturing partners in the coming years we will be completing design freeze, pre-clinical and clinical trials, human factors studies, DV&V and FDA regulatory submission with the target of launching in the US market following with Europe shortly after. Our Offering Market leading salary and benefits plan, flexible working hours, based in a new, state of the art innovation hub. If you are ready to accelerate your career by joining a team that is at the forefront of innovation & industrial research in the respiratory area specialising in palliative care, we would love to hear from you.

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