Principal Engineer, Design Assurance

Description

About New World Medical

Founded in 1990, New World Medical is a mission-driven company focused on preserving and enhancing vision through innovative ophthalmic surgical devices, including the Ahmed Glaucoma Valve and Kahook Dual Blade. We partner closely with eye care professionals to deliver tools that improve clinical outcomes and patient care. Guided by our core values - Gratitude, Collaboration, and Impact, we strive to make a meaningful impact in eye health worldwide. In support of our global mission, we proudly donate surgical equipment to charitable organizations to expand access to quality eye care.

Benefits starting Day One:

• Medical, Dental, and Vision Insurance
• 401(k) with Profit Share
• Bonus Opportunities
• Career Development Program
• Tuition Assistance (after 1 year of service)
• Cell Phone Stipends
• Wellness & Employee Assistance Programs
• Company Events & Recognition
• And more!

Be part of something meaningful join the team at New World Medical.

JOB SUMMARY:

The Principal Engineer, Quality Design Assurance serves as a quality engineering technical leader supporting new product development, clinical development, design transfer, and sustaining activities throughout the product lifecycle. The role partners cross-functionally with R&D, Engineering, Regulatory Affairs, Manufacturing, Clinical, Operations, and other functions to ensure appropriate application of design controls, risk management, verification and validation, and Quality Management System requirements. The Principal Engineer, Quality Design Assurance provides independent quality oversight, leads resolution of complex technical and compliance issues, establishes and promotes quality engineering best practices, and ensures objective evidence demonstrates that product designs and manufacturing processes meet applicable user needs, design requirements, regulatory requirements, and company quality standards.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Provides design assurance leadership across the product lifecycle, including design inputs, outputs, reviews, verification, validation, transfer, and changes.
• Partners with cross-functional teams to define clear, testable requirements and maintain design-control traceability.
• Provides independent oversight of risk management activities in accordance with ISO 14971 and company procedures.
• Leads and participates in phase reviews and design reviews, ensuring actions and decisions are documented and resolved.
• Provides quality oversight for clinical and investigational device builds, including design maturity, configuration, risk, verification/validation, deviations, and changes.
• Reviews and approves verification and validation strategies, protocols, reports, acceptance criteria, and objective evidence.
• Supports qualification and validation of inspection and test methods using appropriate statistical techniques.
• Partners with Regulatory Affairs to assess regulatory impact of new products and product changes.
• Supports sustaining changes to products, suppliers, manufacturing processes, and related verification/validation activities.
• Provides quality oversight of design transfer, manufacturing readiness, supplier controls, and process validation, including IQ/OQ/PQ as applicable.
• Supports supplier selection, qualification, monitoring, development, and audits.
• Applies statistical methods to design verification, test methods, process validation, capability studies, and investigations.
• Ensures compliance with applicable QMS requirements, FDA QMSR, ISO 13485, ISO 14971, EU MDR, CMDR, and other global requirements.
• Serves as a subject-matter expert and mentor in design controls, risk management, quality engineering, and product development.
• Leads resolution of complex quality and compliance issues and drives continuous improvement.
• Performs other duties as assigned.

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• Expert knowledge of medical device design controls, risk management, verification/validation, design transfer, and product development.
• Demonstrated technical leadership, cross-functional influence, problem solving, and risk-based decision making.
• Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and other applicable medical device requirements.
• Strong technical writing and review skills for protocols, reports, risk files, requirements, and design-control records.
• Strong statistical knowledge and experience with Minitab or equivalent statistical software.
• Excellent written, verbal, presentation, collaboration, and interpersonal skills.
• Strong project management, prioritization, analytical, and problem-solving skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Experience with software, firmware, cybersecurity, or combination-product design assurance preferred, as applicable.

EDUCATION AND EXPERIENCE:

• Bachelor's degree in an engineering or science field required; advanced degree preferred.
• 7+ years of experience in medical devices.
• Experience supporting products through development, clinical use, design transfer, commercialization, and sustaining activities preferred.
• Relevant quality or regulatory certifications, such as ASQ or RAPS, preferred.

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time, including sitting at a desk and working on a computer.
• Occasionally move about inside the office and travel to and from office buildings. This may include, but is not limited to, bending and walking.
• Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
• Occasionally lift up to 15 pounds. This may be performed with reasonable accommodation.
• Ability to listen and speak with others. Must be able to exchange accurate information in these situations.
• View and type on computer screens for long periods of time.

This description reflects management's assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.