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Sr. Mechanical Engineer
2 months ago
RESPONSIBILITIES:
• Research, design, develop, and test electromechanical devices for VAD and CPB applications
• Work with cross-functional teams for development of new products, and improvement to existing products driven by
corrective and preventative actions (CAPA)
• Establish requirements (User Needs and Design Input Requirements) and specifications for these products
• Use experimental, empirical, and numerical analysis to evaluate designs.
• Develop and qualify (IQ/OQ) fixtures/equipment for verification testing
• Investigate issues and identify root causes in complex systems where analysis of situations or data requires an in-
depth evaluation of various factors
• Identify and mitigate both technical risks and program (scope, schedule, budget) risks
• Create/review technical drawings for appropriate assembly, dimensioning, and tolerancing
• Support projects in various capacities: i.e. as an individual contributor, as technical lead of a small team, or a subject-
matter expert/consultant
• Maintain a detailed understanding of the developing clinical environment (e.g. current treatment methods, evolving
clinical needs etc.).
• Provide input and support to Regulatory Affairs for FDA/global regulatory submissions
• Aid in vendor evaluations such as manufacturing capability and capacity, engineering support, and quality controls
• Complies with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes,
and task assignments. Maintains positive and cooperative communications and collaboration with all levels of
employees, customers, contractors, and vendors
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),
Environmental Management Systems (EMS), and other regulatory requirements.