Director of Engineering

The Director of Engineering is responsible for leading and managing all engineering functions associated with the design, development, validation, and lifecycle support of electromechanical medical device components and manufacturing processes. This position oversees a multidisciplinary team of approximately twelve mechanical and electrical engineers and ensures that engineering activities support company objectives for product performance, manufacturability, regulatory compliance, and operational efficiency.

The organization designs and manufactures brushless DC motors and hermetically sealed motor controller electronics used in orthopedic surgical handpieces and other medical device applications. The Director of Engineering must possess a strong technical understanding of these technologies and the engineering principles required to design, manufacture, test, and validate them in a regulated environment.

The Director of Engineering is accountable for ensuring that engineering activities comply with applicable regulatory and quality system requirements including ISO 13485 and FDA Quality System Regulations, while meeting customer specifications and supporting the successful transition of products from development through production and lifecycle support.

Essential Duties and Responsibilities

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 Management

• 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.

The Director of Engineering is responsible for ensuring that engineering activities are executed in accordance with the company’s quality management system and documented procedures.

Engineering leadership must maintain a culture of technical discipline, accountability, and regulatory compliance. The Director of Engineering is responsible for ensuring that engineering personnel understand and comply with company procedures, training requirements, and regulatory obligations.

Engineering activities must be properly documented, reviewed, and maintained to support regulatory compliance, internal audits, and customer audits.

Reporting Structure

The Director of Engineering reports directly to the Chief Technical Officer (CTO) and the Chief Operating Officer (COO) and works closely with the Executive Leadership Team to ensure alignment between engineering strategy, product development, manufacturing capability, and organizational objectives.

Qualifications

Education

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline.

Advanced degree preferred.

Experience

• Minimum of 10–15 years of engineering experience in a regulated manufacturing environment.
• Minimum of 5 years of leadership experience managing engineering teams.
• Direct experience in the design, development, manufacturing, or testing of brushless DC motors, motor control electronics, or hermetically sealed electronic assemblies is required.
• Experience working within quality management systems compliant with ISO 13485 and FDA Quality System Regulations is required.

Knowledge and Skills

• 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.
• Strong leadership, organizational, and problem‑solving skills.
• Ability to communicate effectively with customers, executive leadership, and cross‑functional teams.

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