Staff Mechanical Engineer

Job Summary:

Lead mechanical design and development of medical-grade sterilization systems, ensuring compliance with quality and regulatory standards.

Key Responsibilities:

• Lead mechanical design projects for new or modified product

• Develop and validate design concepts using CAD, FEA, and CFD tools, driving innovative solutions for complex engineering challenges.

• Provide technical leadership and mentor junior engineers

• Own design documentation and lead technical reviews, ensuring accuracy and adherence to QMS requirements.

• Collaborate cross-functionally to align design inputs and outputs

• Partner with suppliers and development partners to optimize component design and manufacturability

• Drive continuous improvement in mechanical design processes, tools, and standards.

• Performs Failure Analyses and Investigation reports.

• Mentor junior engineers,

Education and Experience:

• Bachelor’s degree in Mechanical Engineering

• 10+ years of experience in new product development, preferably in regulated industries

• Minimum 6 years of CAD design experience (SolidWorks preferred)

Role and Competencies Requirements

• Expertise in design verification and validation

• Strong communication and collaboration skills

• Strong knowledge of design for manufacturing and testability.

• Proficiency in plastics design and GD&T

• Experience in medical device development preferred

• Knowledge of fluidic systems and sterilization processes a plus

• Ability to lead projects and influence cross-functional teams

• Uses general hand and laboratory tools.

• Proficiency in Microsoft Office and Visio.

• Domestic and International travel as required