Director of Engineering (Brooksville)

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.