19 Mechanical Engineer(Medical device) Jobs in Pleasanton, CA
TekOne IT Services Pvt. Ltd. is Hiring a Mechanical Engineer(Medical device) Near Pleasanton, CA
Location: Pleasanton, CA - 94588
Duration: 12 Months
Job Description
- 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.
- B.S. in Mechanical, Biomedical, or Manufacturing Engineering.
- 8 years engineering experience including product development, process development, risk assessment, and V&V verification related to class II/III medical devices
- Industry experience with FDA design controls 21 CFR 820.30
- Strong communication and presentation skills (e.g. versatility communicating with peers, management, auditors/regulators, and customers)
- Ability to travel approximately 10%, primarily in the US, but may include international)
Job Summary
Full Time
$100k-124k (estimate)
09/11/2024
03/05/2025
The job skills required for Mechanical Engineer(Medical device) include Collaboration, Product Development, Presentation, Initiative, etc. Having related job skills and expertise will give you an advantage when applying to be a Mechanical Engineer(Medical device). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Mechanical Engineer(Medical device). Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Mechanical Engineer(Medical device) positions, which can be used as a reference in future career path planning. As a Mechanical Engineer(Medical device), it can be promoted into senior positions as a Biomedical Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Mechanical Engineer(Medical device). You can explore the career advancement for a Mechanical Engineer(Medical device) below and select your interested title to get hiring information.
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These designers plan mechanical devices and collaborate with other professionals throughout the sketching, building, and testing processes.
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Mechanical engineering creat mechanical design, develop, test, and manufacture machines and other devices.
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Research, testing manufacturing, operations, marketing, and administration are some other key activities associated with practicing Mechanical Engineers.
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