What are the responsibilities and job description for the Director of Engineering position at John Galt Staffing?
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.