Mandatory Skill: Verification, Testing, Test Method Development, Test Method Validation, Lab, ISO 13485, IEC 60601-1, IEC 62366, IEC 62304, ASTM, and ISO 14971

Rate: - $55-$60/hr

Responsibilities:

• The Senior Mechanical Test Engineer will be responsible for planning, performing and documenting system verification, integration and validation activities of complex electro-mechanical systems with software.
• It includes testing of requirements for electro-mechanical systems to ensure proper product components and product functionality.
• The engineer is experienced in all aspects of product development life cycle with strong understanding of systems engineering processes in a regulated industry.
• The Senior Mechanical Test Engineer will work with a multi-disciplinary engineering teams including software, electrical, and mechanical design and test engineers, and other functions to ensure high quality product introductions for class II medical devices.
• We are looking for a motivated self-starter who is energetic, has a ‘make it happen in a compliant way’ attitude and can thrive in a fast-paced environment.

Requirements:

• Lead the mechanical test engineering activities for complex electro-mechanical medical device products within the Product Development team
• Build Mechanical Test Lab, and provide test engineering direction and oversight of testing in the Lab; follow Laboratory Best Practices and safety protocols
• Translate Design Inputs into test design and test protocols, and support creation of system architecture and detailed design documentation
• Develop and maintain system verification and integration planning document, verification protocols, verification reports, requirements documents, and other related technical documentation while ensuring related international standards are applied
• Contribute to risk analysis activities for the product development including hazards analysis, Design FMEA, and Use FMEA
• Ensure that inputs from research, product development and post market are effectively included in design verification related documentation, activities and outputs
• Prepare mechanical test environment and ensure test preconditions are met prior to formal testing activities
• Verify that system and mechanical design and appropriate supporting documentation meets all safety, regulatory and industry compliance standards, and codes while ensuring that related (including ISO 9000, ISO 13485, IEC 60601-1, IEC 62366, IEC 62304, ASTM, and ISO 14971) standards are applied
• Safely work with hazardous systems containing high voltage, high / low temperatures, high acoustic, and high pressure
• Support review and approval of design and process changes as well as deviations related to new and existing medical device products
• Communicate and collaborate with a wide range of project contributors and stakeholders spanning the organization, and external partners including technical leaders for product design, development, integration, testing, and reliability improvements.

Job Type: Contract

Salary: $40.00 - $45.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Irvine, CA: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

Speak with the employer
+91 +12484364789

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