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.
Experience leading complex product development programs from concept through commercialization.
Strong knowledge of FDA Design Controls, ISO 13485, and medical device product development requirements.
Proven experience transferring products from development into manufacturing.
Strong customer-facing and communication skills.
Responsibilities
Lead medical device product development programs from concept through commercialization.
Serve as the primary engineering interface with customers, providing technical guidance.
Manage multidisciplinary engineering teams and project portfolios, establishing priorities.
Drive design controls, risk management, and regulatory compliance activities.
Lead design transfer and manufacturing readiness activities in partnership with Operations and Quality.
Provide technical leadership in resolving complex product development challenges.
Support business development through technical proposals and customer presentations.
Benefits
Opportunity to lead innovative medical device development programs.
Engagement with cross-functional teams and external customers.
Professional development through coaching and mentorship.
Involvement in shaping engineering processes and standards.
Potential for career advancement in a growing company.
Full Job Description
Position Overview:
Argon Medical is seeking a Director of Engineering to lead customer-funded medical device development programs and successfully transfer products into Argon's contract manufacturing operations. This customer-facing leadership role will manage cross-functional teams, oversee design and development activities, and serve as the primary technical partner for external medical device companies seeking development and manufacturing services.
What you will do:
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, establishing priorities and allocating 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 in partnership with Operations and Quality to support successful 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 cross-functionally with Quality, Regulatory, Operations, Supply Chain, and commercial teams to ensure successful execution of 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 that support consistent execution across customer programs.
Develop engineering talent through coaching, technical mentorship, performance management, and succession planning.
Skills for Success:
Supervisory responsibilities
Directly manages engineering professionals and may manage engineering managers or technical leaders. Responsible for team development, resource planning, work direction, performance management, coaching, and building engineering capability to support current and future business needs.
Required education and experience
Bachelor's degree in Engineering or related technical discipline.
12+ years of progressive medical device product development experience required.
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.
Preferred Education and experience
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
Physical demands & Travel required
10-15% Travel
Sedentary
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Argon maintains an employment-at-will relationship with its employees. Nothing in this job description is intended to alter your employment-at-will status with Argon.
