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