Product Development Engineer

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

• 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.
• At least one 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 of risk management techniques, e.g., FMEA and/or ISO 14971.
• Experience in Design for Test (DFT) and Design for Manufacture (DFM).
• 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.

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