Job Description

The Principal Engineer, Product Improvement is a technical leader responsible for the evaluation, development, and execution of design-impacting changes for released medical device products. This role ensures design modifications are executed under design controls in compliance with FDA, ISO 13485, and global regulatory requirements, while maintaining product safety, clinical intent, and performance.

This individual serves as a technical lead across one or more products, translating post-market data, risk assessments, and cross-functional inputs into effective design solutions. The role is responsible for driving technical decision-making within defined product scope and ensuring design changes are robust, well-justified, and compliant.

The Principal Engineer partners closely with other R&D engineers, Quality, Regulatory, Manufacturing, and Supply Chain to support the investigation of product-related issues and ensure that design-related root causes are appropriately addressed through effective design changes. While this role does not own manufacturing process optimization, equipment changes, or non-design-related packaging and labeling updates, it is accountable for the technical rigor and execution of all design-related solutions within assigned scope.

This role has ownership of design-related problem-solving within assigned products and is responsible for defining and executing the technical approach for design-impacting changes. The position is expected to provide sound technical judgment and ensure that design solutions are appropriate, effective, and aligned with product risk and clinical performance expectations.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Lead design-impacting changes including geometry, material, component, and assembly-level modifications for released products within assigned scope
• Own design changes under formal design and change control processes
• Drive CAPA-related design fixes and product performance improvements
• Serve as technical lead for product improvement engineering activities across assigned products
• Ensure Design History File (DHF) integrity, traceability, and completeness for all assigned changes
• Ensure all design changes comply with FDA QSR, ISO 13485, and applicable standards
• Lead risk management activities in accordance with ISO 14971 for assigned scope
• Define and justify verification and validation strategies for design changes
• Support development of protocols, execution, and reporting of verification and validation activities
• Ensure testing demonstrates compliance with design requirements and risk mitigation
• Provide technical rationale and supporting evidence for design changes
• Lead root cause investigations and ensure appropriate design solutions are implemented
• Collaborate cross-functionally to ensure alignment on technical decisions and execution
• Mentor engineers and support development of product improvement engineering capabilities

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong mechanical aptitude with understanding of materials, component interactions, and product performance
• Working knowledge of manufacturing methods, including plastic injection molding and component fabrication
• Ability to generate and interpret engineering drawings
• Strong understanding and application of GD&T and tolerance analysis
• Advanced proficiency in CAD tools (e.g., SolidWorks) to support design modifications and evaluate assemblies
• Ability to review and approve engineering drawings to ensure compliance with design intent and requirements
• Strong understanding of PDM systems for managing product structures, revisions, and configuration control
• Ability to apply established CAD and documentation standards to ensure design integrity
• Strong expertise in medical device design controls, change control, and lifecycle engineering
• Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and global regulatory frameworks
• Competency in risk management and product-design risk methodologies
• Strong analytical and statistical skills for verification and validation justification
• Experience with root cause analysis, CAPA, and product performance investigations
• Ability to lead cross-functional teams and influence without direct authority
• Strong written and verbal communication skills for technical and cross-functional audiences

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in engineering required; Master’s or advanced degree preferred
• 7+ years of engineering experience, including: Experience in medical device R&D or Sustaining engineering; Demonstrated experience executing design-impacting changes and supporting V&V activities; Experience leading technical efforts across cross-functional teams

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.