Director, CPS Engineering

Argon Medical Devices Inc•Plano, TX

About The Position

Argon Medical Devices is seeking a Director of Engineering to lead customer-funded medical device development programs and transfer products into Argon's contract manufacturing operations. This customer-facing leadership role manages cross-functional teams, oversees design and development activities, and serves as the primary technical partner for external medical device companies seeking development and manufacturing services. The Director leads development programs from concept through commercialization, including planning, development, verification, validation, and design transfer. The role manages multidisciplinary engineering teams and project portfolios, establishes priorities and resource allocation, and partners with customers and internal functions to meet program requirements and business needs. It also supports business development, improves engineering processes, and develops engineering talent.

Requirements

Bachelor’s degree in Engineering or a related technical discipline.
12+ years of progressive medical device product development experience.
5+ years of engineering leadership or people management experience.
Demonstrated 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 or programs.
Strong customer-facing, communication, problem-solving, and leadership skills.
Ability to manage engineering professionals and potentially engineering managers or technical leaders.

Nice To Haves

Advanced degree in Engineering, Business, or a related field.
Experience within contract design, development, or manufacturing environments.
Experience working directly with external medical device customers.
Experience supporting business development, technical proposals, product feasibility assessments, or customer project scoping.

Responsibilities

Lead medical device product development programs from concept through commercialization, including planning, development, verification, validation, and design transfer.
Serve as the primary engineering interface with customers, providing technical guidance and maintaining alignment on program requirements, priorities, risks, and deliverables.
Manage multidisciplinary engineering teams and project portfolios, establish priorities, and allocate engineering resources to support business and customer needs.
Drive design controls, risk management, verification, validation, and regulatory compliance 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 product development, design, manufacturing, and customer-related challenges.
Support business development through technical proposals, customer presentations, feasibility assessments, and project scoping.
Partner with Quality, Regulatory, Operations, Supply Chain, and commercial teams to execute development programs.
Monitor program performance and proactively address technical, schedule, resource, and execution risks.
Ensure projects achieve quality, schedule, cost, and customer satisfaction objectives.
Establish and improve engineering processes, technical standards, and development practices.
Develop engineering talent through coaching, technical mentorship, performance management, and succession planning.
Lead team development, resource planning, work direction, performance management, coaching, and engineering capability building.