Job Opening Title: Design Assurance Engineer

Reports to: Director of Quality

About CardiacBooster: CardiacBooster is a medical device company developing a new and innovative device to support the heart. Heart support devices are used by interventional cardiologists to stabilise patients in times of cardiogenic shock and acute heart failure. We are an enthusiastic team with diverse backgrounds and expertise, located in Galway, Ireland, and Nijmegen, Netherlands. CardiacBooster is an equal opportunity employer.

Job Description: A DA Engineer at CardiacBooster will be an experienced engineer with a good knowledge of design processes for medical devices. You will work closely with Quality and Design Assurance counterparts, as well as R&D, Regulatory, Clinical, and marketing functions to support early product design and manufacturing scale-up. You will support the development and regulatory approval of the device and ensure ongoing medical device quality control for the business.

The successful candidate will have entrepreneurial spirit, the required persistence to succeed in a start-up environment, and the ability to work in a self-directed manner with minimal direction and supervision. The DA Engineer will be a team player and have excellent communication skills. This role will work from the company’s office in Ireland, and be in a position to travel occasionally.

Essential Job Responsibilities:

  • Lead the Design Review process in compliance to internal procedures and EU and FDA requirements.
  • Maintain the Design History files, including managing the filing, storage, and retrieval of Design QualityRecords.
  • Work with product development to establish design specifications and product requirements.
  • Ensure all product quality standards and specifications are defined and achieved in line with company andRegulatory requirements including MDR and FDA requirements.
  • Lead risk management process and preparation of risk management files including Use and Design FMEAsas required.
  • In conjunction with the design teams identify product testing required and write design verification andvalidation plans, protocols and reports including specifically advising on sample sizing; including but notlimited to sterilisation, biocompatibility, and distribution testing.
  • Liaise with external suppliers for product testing.
  • Support R&D with initial engagement and set up of component suppliers.
  • Generation and/or review of quality and technical documentation / change requests to support designactivities.
  • Routinely provides design assurance guidance and direction to engineers and/or technicians.
  • Assist Regulatory with the compilation of design dossiers, technical files, essential requirements, andregulatory submissions documentation as required.
  • Support various QA activities including ISO 13485 implementation, quality management, system reviews,internal & vendor audits, etc.
  • Supports set up of process in cleanroom and maintains design to process risk management linkage.

Required Qualifications & Characteristics:

  • Qualification in quality or STEM discipline.
  • Min 3 years’ experience in quality engineering, preferably design assurance, or a similar role.
  • Experience in risk management and usability creation and upkeep.
  • Experience of Design Verification/Validation testing.
  • Experience using quality assurance software tools and processes.
  • Strong communication and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Experience of working effectively in team environments.
  • Ability to provide design assurance guidance and training to other team members.

    Applications:

• Please submit your application, including resume, to hr@cardiacbooster.com

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel as classified.

categories: Quality
locations: Ireland

Apply for this position

Allowed Type(s): .pdf, .doc, .docx