Job Description
Director of Engineering Essential Job Functions: Engineering Leadership Lead, manage, and develop a multidisciplinary engineering team consisting of mechanical, electrical, and manufacturing engineers. Establish engineering priorities aligned with company objectives, regulatory requirements, and customer expectations. Assign engineering resources to product development, validation, production support, and continuous improvement activities. Ensure engineering personnel adhere to company procedures, regulatory requirements, and documented engineering processes. Provide mentorship, technical guidance, and performance oversight for engineering staff. Maintain accountability for engineering deliverables, documentation quality, and project execution. Product Design and Development Oversee all engineering activities related to the design and development of brushless DC motors, hermetically sealed motor controllers, and related electromechanical assemblies. Ensure compliance with design control requirements under ISO 13485 and FDA Quality System Regulations. Approve and oversee development of design plans, design inputs, design outputs, and engineering specifications. Ensure completion of formal design reviews, design verification, and design validation activities. Maintain oversight of Design History Files and related engineering documentation. Ensure engineering documentation accurately reflects product requirements, design decisions, and engineering changes. Risk Management Ensure engineering activities incorporate formal risk management practices in accordance with applicable medical device risk management standards. Oversee development and maintenance of product risk analyses, engineering risk assessments, and failure mode analyses. Ensure appropriate identification of hazards related to motor performance, electronics operation, electrical safety, thermal performance, and reliability. Verify that risk mitigation strategies are implemented and documented. Process Development and Validation Oversee engineering development and implementation of manufacturing processes used to produce brushless motors and sealed electronic assemblies. Ensure manufacturing processes are capable, repeatable, and appropriately validated when required. Ensure validation activities follow documented company procedures and include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as appropriate. Maintain oversight of engineering responsibilities related to the company’s Master Validation Plan. Design Transfer and Production Readiness Ensure effective transfer of product designs from development into production. Oversee preparation and release of manufacturing documentation including engineering drawings, specifications, assembly instructions, and test procedures. Ensure production processes are capable of consistently producing products that meet design requirements and customer specifications. Ensure engineering teams support manufacturing during product launch and production ramp-up. Production Engineering and Continuous Improvement Provide engineering leadership in support of manufacturing operations and production performance. Monitor manufacturing performance including yields, process capability, and engineering-related production metrics. Lead engineering investigations related to production issues, product defects, or nonconforming material. Ensure engineering participation in corrective and preventive action investigations when engineering root causes are identified. Drive engineering improvements that enhance product quality, manufacturability, and operational efficiency. Customer and Technical Interface Serve as the primary engineering liaison for customers regarding technical matters related to product design, performance, and manufacturing processes. Support technical discussions, engineering reviews, and customer audits. Coordinate engineering responses to customer technical inquiries, product complaints, and field performance issues. Ensure engineering commitments to customers are technically sound and properly documented. Supplier Engineering Oversight Provide engineering oversight of critical suppliers whose products or services impact product quality or performance. Support supplier qualification activities and technical evaluations. Ensure appropriate engineering involvement