Design Verification Test Engineer required by Innovative MedTech company based in Dublin to contribute to the development of advanced medical devices. You should have an Electro-Mechanical background with direct experience working with a QMS within a DFT / DFM environment.

REQUIREMENTS: 

• Degree in Engineering or related fields (Electrical, Electronic or Mechanical Engineering preferred)
• 5+ years’ industry experience in an engineering role
• An understanding of quality management system principles (e.g., ISO 9001 or ISO 13485) and/or FDA design and development processes to 21 CFR part 820
• 1+ year experience in electrical and/or mechanical verification (Design Verification Testing/ DVT), including the drafting of test protocols, executing or overseeing the execution of testing, and authoring of test reports
• Experience and/or knowledge of risk management techniques, e.g., FMEA and/or ISO 14971.
• Experience in Design for Test (DFT) and Design for Manufacture (DFM)
• Familiarity in the use of project management tools such as MS Project or SmartSheet
• A team player with excellent interpersonal, communications and problem-solving skills
• Ability to present ideas and concepts clearly and effectively to all levels of the company

ADVANTAGEOUS:

• Relevant experience in medical device design or manufacturing
• Experience in design and testing for electromagnetic compatibility (EMC), e.g., to the Radio Equipment Directive, Federal Communications Commission (FCC) or other EMC standards
• Knowledge and understanding of international safety standards such as IEC 60601, IEC 69050 or IEC 60065
• Experience in the application of statistical principles within an engineering discipline, including sample size calculations and statistical analyses, with experience in the use of statistical software such as R, STATA or Matlab

RESPONSIBILITIES: 

• Develop comprehensive test protocols for various testing domains including, electronic circuit design verification (DVT), mechanical design verification testing, sound stimulation functional testing, electrical stimulation functional testing, packaging integrity testing, transport validation, ingress protection testing, electromagnetic compatibility testing and wireless coexistence testing

• Collaborate with design and development teams to ensure test protocols are aligned with design requirements, manufacturing requirements and applicable regulatory requirements

• Participate in bench testing (Design Verification Testing) of medical device products based on the developed protocols, ensuring rigorous and thorough execution

• Oversee third-party or internal team testing activities, ensuring adherence to protocols and the integrity of the test results

• Analysis of test results including, where appropriate, the application of statistical methods

• Documentation of the test results, ensuring accurate record-keeping and comprehensive traceability

• Participate in the Design Change Control Process, ensuring that any changes made to the product design are verified, validated and meet the requirements of applicable procedures and regulations

• Collaborate with design and development teams, offering feedback and guidance based on testing outcomes to refine the design

• Engage in risk analysis activities, identifying potential design and usage risks, and ensuring they are adequately assessed, controlled and reported

• Assist with document control, ensuring that all design, test, and validation documentation is properly maintained, updated and compliant with applicable QMS procedures

• Participate in the Design, Development & Validation of Manufacturing Equipment, particularly focusing on printed-circuit board test fixtures

• Collaborate with manufacturing and quality assurance teams to ensure equipment meets both production and regulatory requirements

• Validate manufacturing equipment and tools, ensuring they are fit for purpose and meet the defined specifications

• Continuous Improvement: Stay updated with the latest industry standards, regulations, and best practices related to verification and validation

• Provide training to junior team members or cross-functional teams on best practices in design validation and verification

• Continuously seek opportunities to improve testing methodologies, tools, and processes.

• Work closely with other departments, including design, manufacturing, regulatory affairs, and quality assurance, ensuring alignment of goals and seamless communication.

• Present test findings to relevant stakeholders, ensuring clarity of results, inferences and conclusions of the results and their associated implications to the product development process.