Principal Design Assurance Engineer

<meta><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:8pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><b><strong style="font-size:15pt;white-space:pre-wrap;">About the role</strong></b></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><span style="font-size:11pt;white-space:pre-wrap;">The </span><b><strong style="font-size:11pt;white-space:pre-wrap;">Principal Design Assurance Engineer</strong></b><span style="font-size:11pt;white-space:pre-wrap;"> supports product design and development activities and ensures the effective transfer of new products into manufacturing. This role partners closely with Regulatory, Operations, and Engineering teams to ensure compliance with applicable regulatory requirements and company standards.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><span style="white-space:pre-wrap;">The position is responsible for lifecycle management of assigned products, including maintenance of Design History Files (DHF) and Design Risk Management documentation.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><span style="white-space:pre-wrap;">This role applies hands-on electrical engineering expertise to support the design, analysis, verification, and sustaining of medical devices, including analog and digital circuits, power management, embedded systems, and electromechanical interfaces. The engineer interprets and evaluates electrical schematics, PCB layouts, component selection, and design tradeoffs to ensure alignment with design inputs, risk controls, and regulatory requirements.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><span style="white-space:pre-wrap;">The role serves as a technical bridge between Design Engineering and Quality by providing informed review and challenge of electrical design decisions.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><span style="white-space:pre-wrap;">In addition, this position supports nonconformance, CAPA, and complaint investigations and acts as a subject matter expert in hardware and electrical design controls, product and system risk management, robust design practices, test method development and validation, and technical investigations.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:8pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><b><strong style="font-size:15pt;white-space:pre-wrap;">What you'll do</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;"><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Provide Design Assurance leadership throughout the design and development of new hardware and electrical medical device products</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Support post-market sustaining activities including failure analysis, design change development and implementation, supplier performance evaluation, certifications, complaint investigations, and nonconformance disposition</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Lead root cause investigations, corrective action development, and verification of effectiveness</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Lead and support compliant development, verification, validation, and transfer of new products and processes into manufacturing</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Serve as a subject matter expert in hardware and electrical design controls, risk management, verification &amp; validation, and DHF maintenance</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Support new process development, test method development and validation, process characterization, and technical investigations</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Lead and participate in design verification and validation activities with clear documentation</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ensure hardware and electrical designs meet regulatory and company standards for quality, safety, performance, and reliability</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Apply sound engineering methodologies to resolve technical issues and drive improvements</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Collaborate with Product Development, Sustaining Engineering, Quality, Regulatory, and Operations teams</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Participate in design reviews and phase-gate reviews</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Contribute to project planning, cost estimates, schedules, and performance requirements</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Prepare and deliver technical presentations</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Provide leadership and mentoring to engineers and project team members</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Support audits and regulatory inspections</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Provide backup support for other QA functions</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Perform other duties as assigned</span></li></ul><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:8pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><b><strong style="font-size:15pt;white-space:pre-wrap;">Qualifications</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;"><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering, or related discipline with </span><b><strong style="white-space:pre-wrap;">10+ years of progressive experience</strong></b><span style="white-space:pre-wrap;">, or equivalent combination of education and experience</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Experience applying hardware and electrical design controls in regulated industries</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Quality engineering experience or certification preferred</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Strong knowledge of:</span><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Medical device design controls</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Risk management</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">New product development</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">DHF maintenance</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Verification and validation testing</span></li></ul></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Experience with test method development and validation</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Strong communication skills with ability to explain technical concepts clearly</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Demonstrated ability to lead technical teams through collaboration and influence</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">In-depth knowledge of applicable regulations and standards, including:</span><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">FDA 21 CFR Part 820</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ISO 13485</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ISO 14971</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">IEC 60601</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">IEC 61010 (as applicable)</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ISO 10993 (as applicable)</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">EU MDR</span></li></ul></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Strong analytical and problem-solving skills</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ability to work independently while exercising sound judgment</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Proficiency with Microsoft Office and engineering/documentation tools</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Strong organizational and time-management skills</span></li><li style="font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Demonstrated success achieving quality and compliance objectives</span></li></ul><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:15pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;"><b><strong style="font-size:15pt;white-space:pre-wrap;">Equal Opportunity Employer</strong></b></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:12pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;"><span style="white-space:pre-wrap;">MicroTransponder, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.</span></p><h2 style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;line-height:1.6;font-size:15pt;font-weight:600;letter-spacing:0.5px;margin-top:18px;margin-bottom:4px;text-align:start;padding-left:0px;"><span style="white-space:pre-wrap;">Benefits</span></h2><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:12pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;"><span style="white-space:pre-wrap;">MicroTransponder provides a comprehensive benefits program to employees.&nbsp; It includes medical, dental and vision plans along with an FSA.&nbsp; Employees may participate in the company 401(k) plan with company matching.&nbsp; The company offers an unlimited Paid Time Off (PTO) program and approximately 18 paid company holidays per year.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;"><span style="color:rgb(255,255,255);font-size:11.25pt;white-space:pre-wrap;">Apply now</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;"><br></p> <meta><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:8pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><b><strong style="font-size:15pt;white-space:pre-wrap;">About MicroTransponder</strong></b></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;"><span style="white-space:pre-wrap;">MicroTransponder, Inc. is dedicated to transforming the lives of stroke survivors through its innovative neurostimulation technology. The company's flagship product, the FDA-approved Vivistim® Paired VNS™ System, enhances stroke rehabilitation by pairing vagus nerve stimulation (VNS) with physical and occupational therapy. This approach leverages the brain's neuroplasticity to improve upper limb function, offering new hope to those with chronic arm and hand impairments following an ischemic stroke.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;"><span style="white-space:pre-wrap;">By integrating this therapy into rehabilitation programs, MicroTransponder aims to help stroke survivors regain independence in daily activities and enhance their quality of life. The company's commitment to advancing stroke recovery is evident in its ongoing research and collaboration with healthcare providers to make this therapy accessible to more patients.</span></p>