Director of Medical Device Engineering & Customer Programs

Argon Medical Devices Inc; Plano (TX); On-site; USD 180,000 - 240,000; Full time

Job summary

Argon Medical Devices Inc in Plano, Texas, seeks a Director of Engineering to lead customer-funded medical device development programs and transfer products into contract manufacturing operations.

You will manage cross-functional teams, oversee design controls, risk management, verification/validation, and regulatory compliance, and serve as the primary technical partner for external medical device companies seeking development and manufacturing services.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 12+ years of progressive medical device product development experience.
• 5+ years of engineering leadership or people management experience.
• Strong knowledge of FDA Design Controls, ISO 13485, risk management, verification and validation.
• Proven experience transferring products from development into manufacturing.
• Demonstrated experience leading cross-functional technical teams and managing multiple projects.
• Strong customer-facing, communication, problem-solving, and leadership skills.

Responsibilities

• Lead medical device product development programs from concept through commercialization.
• Serve as the primary engineering interface with customers, providing technical guidance and aligning on requirements, priorities, risks, and deliverables.
• Manage multidisciplinary engineering teams and project portfolios, allocating resources to support business and customer needs.
• Drive design controls, risk management, verification, validation, and regulatory activities throughout the product development lifecycle.
• Lead design transfer and manufacturing readiness activities with Operations and Quality to support commercialization.
• Provide technical leadership in resolving complex development, manufacturing, and customer-related challenges.
• Support business development through technical proposals, feasibility assessments, and project scoping.
• Partner with Quality, Regulatory, Operations, Supply Chain, and commercial teams to ensure successful execution of programs.
• Monitor program performance and address risks proactively.
• Ensure projects meet quality, schedule, cost, and customer satisfaction objectives.
• Establish and improve engineering processes and standards across programs.

Skills

Engineering leadership

Cross-functional collaboration

Regulatory knowledge

Client communication

Education

Bachelor’s degree in Engineering or related technical discipline

Advanced degree (preferred)

Job description

Argon Medical Devices Inc in Plano, Texas, seeks a Director of Engineering to lead customer-funded medical device development programs and transfer products into contract manufacturing operations.

You will manage cross-functional teams, oversee design controls, risk management, verification/validation, and regulatory compliance, and serve as the primary technical partner for external medical device companies seeking development and manufacturing services.