Director Medical Device Product Development Jobs

• 2–5 years of experience: Starting at $105,000
• 6–9 years of experience: Progressively higher based on experience, skills, and performance
• 10+ years of experience: Up to $165,000

Be part of a mission that matters—join Arrotek, a Theragenics company, as a Senior Interventional Device Development Engineer and help bring innovative medical technologies from concept to commercialization. In this critical role, you'll lead the design, development, optimization, and transfer of advanced interventional medical devices, including catheter and guidewire technologies that improve patient outcomes worldwide.

Working alongside multidisciplinary engineering teams, manufacturing experts, and global clients, you'll play a key role in developing life-changing solutions that enable physicians to perform safer, less invasive procedures. If you're passionate about innovation, technical excellence, and making a meaningful impact in healthcare, this is your opportunity to help shape the future of medical technology.

At Theragenics, we're passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what's possible, ensuring a brighter future for patients everywhere.

Theragenics is a leader in developing medical devices focused on minimally invasive treatments for cancer, vascular interventions, and surgical applications. Headquartered in Atlanta, Georgia, the company operates facilities in Costa Rica, Texas, and Massachusetts.

Theragenics proudly operates Arrotek, a leading medical device design and development consultancy with locations in the United States and Ireland. Arrotek specializes in pioneering minimally invasive technologies that improve lives through innovative engineering, product development, and manufacturing solutions.

As a Senior Interventional Device Development Engineer, you will apply advanced engineering expertise to lead the development of innovative interventional medical devices from concept through commercialization. You will serve as a technical leader across development programs, mentor junior engineers, collaborate directly with clients, and drive the successful execution of complex product and process development projects in a highly regulated environment.

• Lead the design and development of interventional medical devices, including catheters, guidewires, and electromechanical systems.
• Generate innovative concepts and evaluate designs through engineering analysis, prototyping, testing, and design reviews.
• Develop, optimize, and validate manufacturing and assembly processes, including extrusion, reflow, tipping, bonding, laser processing, and precision assembly.
• Execute and lead Design of Experiments (DOE), feasibility studies, verification, and validation activities.
• Conduct risk assessments, FMEA activities, and design control reviews throughout the product lifecycle.
• Develop and maintain technical documentation including DHFs, DMRs, BOMs, drawings, protocols, and engineering reports.
• Lead technical workstreams and support project planning, scheduling, budget management, and deliverable execution.
• Interface directly with customers to communicate project status, technical recommendations, and development strategies.
• Mentor and provide technical guidance to junior engineers and project team members.
• Collaborate with Quality, Regulatory, Manufacturing, Supply Chain, and external partners to ensure successful product development and commercialization.
• Support manufacturing transfer, process scale-up, root cause investigations, and continuous improvement initiatives.
• Ensure compliance with FDA, ISO 13485, ISO 14971, MDR, and applicable regulatory requirements.

• Bachelor's degree in Biomedical, Mechanical, Manufacturing, Plastics, Polymer Engineering, or a related engineering discipline.
• 5–10 years of experience in medical device product development, preferably focused on catheter, guidewire, or minimally invasive technologies.
• Demonstrated experience leading technical development activities within a regulated medical device environment.
• Strong knowledge of design controls, risk management, verification and validation, and product lifecycle management.
• Experience developing and optimizing manufacturing processes for medical devices.
• Excellent technical communication, project leadership, and problem-solving skills.

• Master's degree in Engineering or related technical field.
• Experience within a contract design and manufacturing organization (CDMO) environment.
• Expertise in catheter or guidewire development technologies.
• Experience with customer-facing engineering and project leadership.
• Strong knowledge of FDA, ISO 13485, and MDR requirements.

• Medical Device Product Development
• Catheter & Guidewire Engineering
• Design Controls & Product Lifecycle Management
• Design for Manufacturability (DFM)
• Design of Experiments (DOE)
• Verification & Validation (V&V)
• Risk Management & FMEA
• Process Development & Optimization
• Manufacturing Transfer & Scale-Up
• Prototype Development & Testing
• Statistical Analysis & Data Interpretation
• Root Cause Analysis & Problem Solving
• Technical Documentation
• FDA & ISO 13485 Compliance

• Technical Leadership
• Coaching & Mentoring
• Stakeholder Management
• Influencing Without Authority
• Cross-Functional Collaboration
• Strategic Thinking
• Customer Focus
• Innovation & Continuous Improvement
• Program Awareness
• Results Orientation

• Lead cutting-edge medical device development programs that directly impact patient care.
• Collaborate with industry-leading engineers, clinicians, and global customers.
• Work on innovative catheter and guidewire technologies from concept through commercialization.
• Expand your technical leadership and career growth opportunities.
• Be part of a highly collaborative and mission-driven culture.
• Receive competitive compensation and comprehensive benefits.

“We don’t just develop devices; we create solutions that help clinicians improve and extend lives.”