Job Description
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