Director of Medical Device Engineering & Customer Programs

Argon Medical Devices, Inc.; Plano (TX); On-site; USD 150,000 - 230,000; Full time

Job summary

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

You will manage cross-functional teams, guide design and development, and serve as the primary technical partner for external clients. The role requires a Bachelor’s in Engineering, 12+ years in medical device development, and 5+ years of leadership, with strong knowledge of FDA Design Controls and ISO 13485.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 12+ years of medical device product development experience.
• 5+ years in engineering leadership or people management.
• Experience leading complex product development programs from concept through commercialization.
• Strong knowledge of FDA Design Controls, ISO 13485, risk management, verification and validation, and medical device product development requirements.
• 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 primary engineering interface with customers, guiding requirements and priorities.
• Manage multidisciplinary engineering teams and project portfolios.
• Drive design controls, risk management, verification, validation, and regulatory activities.
• Lead design transfer and manufacturing readiness with Operations and Quality.
• Provide technical leadership in resolving development and manufacturing challenges.
• Support business development through technical proposals and feasibility assessments.
• Collaborate with Quality, Regulatory, Operations, Supply Chain, and commercial teams.
• Monitor program performance and address risks to schedule and cost.
• Ensure project success in quality, schedule, cost, and customer satisfaction.

Skills

Leadership

Customer-facing comms

Project management

Cross-functional leadership

Education

Bachelor’s degree in Engineering

12+ years medical device development

5+ years engineering leadership

Job description

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

You will manage cross-functional teams, guide design and development, and serve as the primary technical partner for external clients. The role requires a Bachelor’s in Engineering, 12+ years in medical device development, and 5+ years of leadership, with strong knowledge of FDA Design Controls and ISO 13485.