Manager’s Note

–Mechanical testing background.

–NOT looking for design test or supervisory experience.

-With MS 10-15 years of experience.

–Medical device testing of biocompatibility testing, labeling testing and more.

–Electro mechanical software testing.

–Electrical, mechanical and software tester.

-NOT looking for engineer’s.

–V&V, R&D test engineer.

-Open for relocating candidate

–Calibrate, optical device, visual inspection test for labeling testing/verification

-DHF -design history files, ALM

-Hybrid 3 in office/2 day remote

Job Description

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.

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
• 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

Skills Required

• Performing mechanical Design Verification tests for medical devices (including flexile, impact, flexural, torsion, fatigue, packaging, labeling, biocompatibility)
• Cross-discipline knowledge (including mechanical, electrical, software, firmware)
• Verification tests documentation (including protocols, reports, deviations)
• Test automation
• Manufacturing tests
• Process management