Director of Engineering

Overview The Director of Engineering is responsible for providing strategic and operational leadership across the organization’s engineering, product quality, and regulatory compliance functions. This role oversees New Product Engineering, Sustaining Engineering, Regulatory & Test Standards, Product Quality, and compliance with applicable quality management systems and regulatory requirements, including ISO standards and FDA regulations. Reporting to the Vice President of Operations, the Director of Engineering serves as a key member of the operational leadership team, ensuring products are designed, validated, manufactured, and sustained in compliance with customer expectations, regulatory obligations, and company performance objectives. This leader is responsible for driving innovation in product development, maintaining and improving existing product performance, ensuring technical and regulatory integrity of the product portfolio, and fostering a culture of engineering excellence, product quality, and continuous improvement. The role requires strong cross-functional collaboration with Operations, Supply Chain, Quality, Manufacturing, Commercial, and Executive Leadership to support growth, product reliability, compliance, and operational effectiveness Responsibilities Engineering Leadership & Strategy Provide strategic leadership across New Product Engineering, Sustaining Engineering, Product Quality, and Regulatory / Compliance functions Establish engineering priorities, resource plans, and execution strategies aligned with business objectives Build and develop a high-performing technical organization through coaching, accountability, and talent development Product Development & Lifecycle Management Lead new product development efforts from concept through commercialization, ensuring disciplined execution of design, testing, validation, and launch activities Oversee sustaining engineering activities to support product performance, reliability improvements, cost optimization, engineering changes, and lifecycle management Ensure strong design-for-manufacturability and cross-functional collaboration to support efficient product launch and long-term product success Regulatory Compliance & Product Quality Ensure compliance with applicable regulatory requirements, technical standards, ISO quality systems, and FDA regulations Oversee engineering verification, validation, product testing, and technical documentation to support product compliance and performance Drive product quality improvement through effective problem-solving, root cause analysis, corrective actions, and continuous improvement initiatives Operational Collaboration & Leadership Partner closely with Operations, Manufacturing, Supply Chain, Quality Assurance, and Commercial teams to align engineering priorities with business needs Provide technical leadership in support of manufacturing performance, supplier quality, product issue resolution, and operational improvement initiatives Communicate effectively across all levels of the organization while driving accountability, execution, and results Qualifications Education and Experience: Required: Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline Minimum of 12–15 years of progressive engineering leadership experience within a manufacturing environment Minimum of 5–7 years of leadership experience managing engineering teams and technical professionals Demonstrated experience leading new product development efforts from concept through commercialization Proven experience overseeing sustaining engineering / product lifecycle management in a manufacturing environment Strong working knowledge of engineering validation, product verification, testing methodologies, and technical standards Experience with regulated quality systems and compliance requirements, including ISO standards and FDA regulatory environments Demonstrated success leading cross-functional teams in support of product quality, engineering execution, and business objectives Preferred: Master’s degree in Engineering, Business Administration, or related discipline Professional Engineering (PE) license, Six Sigma certification, or equivalent technical / operational certifications Experience within medical device, healthcare products, mobility products, or similarly regulated manufacturing environments Experience with design controls, risk management methodologies, product validation, and change management processes Working knowledge of global regulatory requirements and international product compliance standards Experience leading engineering teams through organizational growth, transformation, or product portfolio expansion Skills and Abilities: Strong leadership and communication skills with the ability to analyze and synthesize technical, quality, regulatory, and business information into clear, actionable recommendations. Proven ability to influence and collaborate effectively across cross-functional teams, including Operations, Supply Chain, Quality, Commercial, and Executive Leadership. Capable of representing the company effectively with customers, suppliers, regulatory agencies, and certification bodies as needed. Strong written communication skills with the ability to develop clear technical documentation, executive updates, engineering procedures, and compliance-related materials. Proficient with Microsoft Office and relevant engineering, quality, and business systems, with the ability to leverage data and technology to improve product performance, engineering execution, and operational effectiveness. Maintains current knowledge of industry standards, regulatory requirements, engineering best practices, and emerging technologies, with a demonstrated ability to drive innovation, product quality improve