74 Sr. Mechanical Engineer Jobs in Pleasanton, CA
TekOne IT Services Pvt. Ltd. is Hiring a Sr. Mechanical Engineer Near Pleasanton, CA
Location: Pleasanton, CA - 94588
Duration: 12 Months
Job DescriptionPOSITION SUMMARY:
Performs complex activities in the design and testing of class II and class III mechanical circulatory support products
including VADs, extracorporeal blood pumps, oxygenators, and CPB cannula. Provides technical solutions to a wide
range of difficult problems. Exercises considerable latitude in determining technical objectives and solutions of
assignments. May direct projects and activities of other Engineers and Technicians.
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
- 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-
- 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-
- Maintain a detailed understanding of the developing clinical environment (e.g. current treatment methods, evolving
- 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,
employees, customers, contractors, and vendors
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),
Job Summary
Full Time
$125k-151k (estimate)
09/11/2024
03/05/2025
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