New Product Development Engineer II

Job Summary

The NPD Engineer II – Design is responsible for independently executing the design and development of medical devices from concept through commercialization. This role focuses on detailed product design, engineering analysis, and supporting product development activities to deliver high-quality solutions that meet customer and business needs.

Job Responsibilities

• Supports design and development activities across the product lifecycle, including concept, design, and verification/validation phases.
• Affords assistance in translating customer requirements into engineering specifications and design inputs.
• Contributes to component and sub-system design efforts under guidance from Senior Engineers.
• Supports development of designs that meet performance, reliability, and regulatory requirements.
• Supports design for manufacturability (DFM) and design for assembly (DFA) efforts.
• Assists in execution of design control processes, including documentation, risk management activities, and verification/validation testing.
• Participates in identifying technical risks and contributes to mitigation activities.
• Assists with engineering change documentation and implementation.
• Supports execution of experiments, testing, and analysis to evaluate product performance.
• Applies fundamental engineering principles to solve defined technical problems with guidance.
• Uses basic analytical and statistical tools to support design decisions and data evaluation.
• Assists in evaluation of materials, components, and design options.
• Works with cross-functional teams including engineering, manufacturing, quality, and regulatory to support product development and transfer activities.
• Participates in design reviews and team discussions.
• Contributes to assigned tasks and project deliverables with guidance from Senior Engineers.
• Supports documentation, reporting, and project timelines.
• Assists technicians and participates in prototyping and testing activities.

Requirements

• Bachelor’s degree in Engineering
• Six Sigma Green/Black Belt (preferred)
• 2–5 years of medical device design experience
• Working knowledge of design controls, product development, and verification/validation methods
• Proficiency in 3D CAD (SolidWorks preferred) and familiarity with GD&T/drafting
• Experience with analytical and statistical tools (DOE, tolerance analysis, etc.)
• Experience in regulated environments
• Strong technical writing and documentation skills
• Effective communication and collaboration skills
• Demonstrated ability to work independently and own defined design tasks or workstreams
• Ability to support and guide technicians or junior team members