Director of Engineering

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 in supplier-related investigations and corrective actions. - Assist in development of engineering specifications and incoming inspection requirements for critical components. Lifecycle Engineering Responsibility - Ensure engineering involvement continues throughout the lifecycle of products after release to production. - Monitor product performance using production data, field performance information, and customer feedback. - Support failure investigations, root cause analysis, and engineering corrective actions. - Identify opportunities for product improvement, cost reduction, and process optimization. Required Qualifications: - Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline. Advanced degree preferred. - Minimum of 10-15 years of engineering experience in a regulated manufacturing environment. - Minimum of 5 years of leadership experience managing engineering teams. - Experience working within quality management systems compliant with ISO 13485 and FDA Quality System Regulations is required. - Strong understanding of engineering design principles for Brushless DC motors and motor control electronics. - Familiarity with hermetic sealing techniques and sealed electronics assemblies. - Experience with product development processes including design controls, verification, and validation. - Familiarity with manufacturing process development and validation. - Knowledge of quality system requirements applicable to regulated medical device manufacturing environments. - Ability to manage multidisciplinary engineering teams and multiple concurrent projects.