Director of Engineering

The JMA HR Solutions team at James Moore & Co., P.L. is currently partnering with Command Medical Products to find a Director of Engineering who will bring their talent to the team. We are seeking candidates who are eager to join their mission and contribute to the next generation of life-saving devices.

At Command Medical Products, we are pioneers in the medical device industry, dedicated to improving lives with innovative and reliable solutions. Our dynamic team is passionate about designing and manufacturing high-quality medical products that make a real difference in patient care.

If you're ready to be a part of a forward-thinking company that values creativity, collaboration, and excellence, we want to hear from you!

The Director of Engineering is responsible for driving innovation, aligning engineering initiatives with business goals, ensuring regulatory compliance, and overseeing new product introduction (NPI) and process development across the organization. The Director will serve as a key member of the leadership team and will influence company direction, client engagement, and operational excellence. In addition to providing Strategic direction to the team, he or she will need to provide hands on support periodically.

KEY RESPONSIBILITIES

Strategic Leadership & Organizational Oversight:

• Develop and execute the engineering strategy aligned with corporate objectives, growth targets, and customer requirements.
• Drive technology roadmaps, investment planning, and engineering capability development.
• Lead capital projects related to new technology acquisition, facility expansion, and process innovation.

Team & Functional Leadership:

• Provide leadership to engineering managers, senior engineers, and cross-functional teams.
• Build a high-performing engineering organization through succession planning, recruitment, coaching, and mentoring.
• Foster a culture of technical excellence, innovation, and continuous improvement.

Customer & Business Engagement:

• Collaborate directly with key clients, executive leadership, and business development to define technical requirements and strategic priorities.
• Act as the technical liaison for major customer programs, audits, and proposals.
• Support customer onboarding through NPI, design transfer, and scale-up processes.

Technical & Operational Oversight:

• Oversee design control, validation strategy, process engineering, and technical risk management.
• Ensure consistent application of DFM, DFA, and design control practices across all projects.
• Champion automation, digitalization, and advanced manufacturing technologies.

Regulatory & Quality Leadership:

• Ensure engineering operations remain compliant with FDA, ISO 13485, MDR, and client-specific requirements.
• Serve as the engineering lead for regulatory inspections, quality system audits, and risk management activities.
• Partner with Quality and Regulatory Affairs to maintain robust product lifecycle documentation.
• Education: Bachelor’s degree required; Master’s or advanced technical degree preferred in Engineering or a related field.
• Experience: 10 years of engineering experience with 5 years in a senior leadership role within the medical device or regulated CMO environment.
• Leadership: Proven ability to lead multi-disciplinary engineering teams and cross-functional initiatives.
• Strategic Skills: Demonstrated success in organizational planning, budgeting, capital project management, and executive reporting.
• Regulatory Knowledge: Deep understanding of medical device regulatory frameworks (FDA, ISO 13485, EU MDR).
• Business Acumen: Experience supporting business development, cost modeling, and customer engagements.

REQUIRED QUALIFICATIONS

• Education: Bachelor’s degree required; Master’s or advanced technical degree preferred in Engineering or a related field.
• Experience: 10 years of engineering experience with 5 years in a senior leadership role within the medical device or regulated CMO environment.
• Leadership: Proven ability to lead multi-disciplinary engineering teams and cross-functional initiatives.
• Strategic Skills: Demonstrated success in organizational planning, budgeting, capital project management, and executive reporting.
• Regulatory Knowledge: Deep understanding of medical device regulatory frameworks (FDA, ISO 13485, EU MDR).
• Business Acumen: Experience supporting business development, cost modeling, and customer engagements.

PREFERRED QUALIFICATIONS

• Experience scaling a CMO operation or launching greenfield/brownfield sites.
• Background in advanced automation, digital engineering tools, or Industry 4.0 implementation.
• Experience with extrusion and RF welding is a plus
• Lean Six Sigma Black Belt or equivalent process improvement certification.

WORKING CONDITIONS

Good working conditions in office environment. Work is primarily performed in an office setting with extended periods at a computer and regular exposure to manufacturing and warehouse areas. The nature of the work has frequent interruptions; contact with FDA, ISO, Clients and interoffice staff.

Experience

• 5 year(s): 5 years in a senior leadership role within the medical device or regulated CMO environment.
• 10 year(s): 10 years of engineering experience

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.