Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Engineer III
4410 Rosewood Drive Pleasanton, CA 94588 US
Posted: 02/16/2024
2024-02-16
2024-03-29
Employment Type:
Contract
Job Category: Engineering
Job Number: 599947
Is job remote?: No
Country: United States
Job Description
Pay is commiserate with experience and ranges between $60-70/hr
The 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
Responsibilities
• 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
Qualifications
• Master of Engineering or related technical field
• 10+ years of experience in regulated industry testing complex electromechanical systems
• Firm technical background within medical device testing, development, systems engineering or similar
• Strong understanding of Design Controls for medical device development including experience with medical device product life-cycle processes conforming to standards including ISO 9000, ISO 13485, IEC 60601-1, IEC 62366, IEC 62304, ASTM, and ISO 14971
• Proficient in using Requirement Management and Traceability tools
• Technical leadership or program management experience with strong understanding of project / program management according to regulated product development process
• Hands-on experience with developing design verification protocols, execution, and report generation as well as with conducting mechanical verification of high and low temperature, high acoustic, and high liquid pressure systems
• Basic engineering laboratory skills: weights and measures, chemical hygiene, materials safety planning, personal protective equipment, contamination control, job hazard analysis, and work instruction
• An enthusiastic team builder and player
• Excellent communication, written and personal computer skills
• Ability to earn trust, maintain positive and professional relationships, and strengthen our culture of inclusion
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The 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
Responsibilities
• 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
Qualifications
• Master of Engineering or related technical field
• 10+ years of experience in regulated industry testing complex electromechanical systems
• Firm technical background within medical device testing, development, systems engineering or similar
• Strong understanding of Design Controls for medical device development including experience with medical device product life-cycle processes conforming to standards including ISO 9000, ISO 13485, IEC 60601-1, IEC 62366, IEC 62304, ASTM, and ISO 14971
• Proficient in using Requirement Management and Traceability tools
• Technical leadership or program management experience with strong understanding of project / program management according to regulated product development process
• Hands-on experience with developing design verification protocols, execution, and report generation as well as with conducting mechanical verification of high and low temperature, high acoustic, and high liquid pressure systems
• Basic engineering laboratory skills: weights and measures, chemical hygiene, materials safety planning, personal protective equipment, contamination control, job hazard analysis, and work instruction
• An enthusiastic team builder and player
• Excellent communication, written and personal computer skills
• Ability to earn trust, maintain positive and professional relationships, and strengthen our culture of inclusion
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- What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
- Test automation
- Manufacturing tests
- Process management
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