Lead mechanical design and development of medical-grade sterilization systems, ensuring compliance with quality and regulatory standards.
Key Responsibilities:
Lead mechanical design projects for current 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 recent 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
Solid 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