The Quality Engineer (Electrical) is responsible for supporting electrical medical devices through their full life-cycle. This includes design assurance activities as part of new product development and process/product changes and leading investigations for technically complex and challenging manufacturing nonconformities or post-market failures to identify root cause/corrective actions in a timely and compliant manner. This specific Quality Engineer position will primarily focus on electrical medical devices including implantable pulse generators and programmers.
The Quality Electrical Engineer’s role on new product development teams includes investigating anomalies identified during the development process, providing value-added feedback in technical design reviews, leading risk management activities, ensuring that we are applying the right engineering approaches and methods that meet procedural and regulatory requirements for all phases of development projects including design inputs, design transfer (process validation), design verification and validation, etc.
This person will be working in a cross-functional environment, with a multi-disciplinary team of engineers within the Quality Engineering Department. You will have a demonstrable impact on the patient experience by ensuring that the devices we design, develop, and manufacture are safe and effective. This person will interact on a daily basis with Manufacturing Engineering, R&D Engineering and Project Management, reporting directly to the Sr. Director of Quality Engineering.
• Electrical Engineering BS at a minimum.
• 5+ years of experience in a medical or biotechnology industry involved in supporting electrical engineering activities such as those previously detailed above for electronic medical devices.
• Required knowledge includes electrical design, statistics, and medical device regulations including the QMS processes required to develop and manufacture medical devices.