Senior Mechanical Operations Engineer

Staff Operations Engineer Mechanical

Work Flexibility: Hybrid

What you will do:
• Under supervision, design, develop, modify, and verify mechanical components for medical devices
• Assist with prototyping and bench testing
• Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements
• Under supervision, conduct research and studies to support product design
• Interpret customer needs and understands design inputs
• Understand the product’s intended use and clinical procedures
• Understand fundamental industry standards, design requirements and test strategies which align with regulatory requirements
• With supervision, create or refine engineering documentation, such as the Design History file per company design control procedures
• Learn R&D procedures like design controls and risk management, per the Quality Management System
• With supervision, work with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success
• Learn procedures, policies, processes, systems, and technology required
• Work on problems in limited scope; purposefully learn while gaining experience
• Demonstrate ownership and integrity of work
• Build stable relationships
• Contribute to the project as a team member

What you will need:

Minimum Qualifications (Required):
• Bachelor of Science in Engineering, Mechanical Engineering or BioMedical & 8+ years of work experience

Preferred Qualifications (Strongly desired):
• Fundamental knowledge and understanding of mechanical engineering practices and tools, design principles within a regulated environment.
• Basic knowledge of design and concept generation CAD or CAE modeling tools
• Basic knowledge of analysis tools and statistical methods
• Basic knowledge of materials and manufacturing methods
• Ability to read and Interpret complex drawings

Travel Percentage: 30%

Experience Level

Senior Level