Job Description

Locations

• USA - California – Irvine

Salary

Skills Required

• R&D laboratoryintermediate
• machining operations including millingintermediate
• extrusionintermediate
• SolidWorksintermediate
• medical device design controlsintermediate

Required Qualifications

• High School Diploma, technical certification, or equivalent experience and: 13 years of experience in an R&D laboratory, engineering development, or medical device environment; OR15 years of directly related technical experience (experience, 13 years)
• High School Diploma, technical certification, or equivalent experience and: (experience)
• 13 years of experience in an R&D laboratory, engineering development, or medical device environment; OR (experience, 13 years)
• 15 years of directly related technical experience (experience, 15 years)

Preferred Qualifications

• Experience with machining operations including milling, turning, grinding, polishing, and related fabrication processes is highly preferred (experience)
• Medical device experience supporting structural heart, transcatheter, catheter-based, or implantable technologies is highly preferred (experience)
• Proven catheter and implant prototyping and product development experience is highly preferred (experience)
• Experience performing device, component, material, or system testing. (experience)
• Strong mechanical aptitude and ability to independently solve complex technical problems. (experience)
• Experience with extrusion, laser cutting, laser welding, fluoropolymer processing, thermoplastics, thermosets, and Nitinol (NiTi) processing. (experience)
• Ability to design and fabricate precise tooling utilizing metal and plastic materials. (experience)
• Experience operating and maintaining additive manufacturing equipment and 3D printing technologies. (experience)
• Demonstrated ability to create novel device concepts and platforms from the ground up. (experience)
• Proficiency with SolidWorks and Creo/ProE CAD software. (experience)
• Ability to work independently with minimal supervision in a fast-paced development environment. (experience)
• Strong communication, documentation, and organizational skills. (experience)
• Medical device experience supporting structural heart, transcatheter, catheter-based, or implantable technologies is a huge plus (experience)
• Knowledge of medical device design controls, quality systems, and engineering change processes. (experience)
• Experience managing project expenses, purchase orders, and invoice approvals. (experience)
• Demonstrated ability to work effectively across multidisciplinary teams. (experience)
• Experience with machining operations including milling, turning, grinding, polishing, and related fabrication processes is highly preferred (experience)
• Medical device experience supporting structural heart, transcatheter, catheter-based, or implantable technologies is highly preferred (experience)
• Proven catheter and implant prototyping and product development experience is highly preferred (experience)
• Experience performing device, component, material, or system testing. (experience)
• Strong mechanical aptitude and ability to independently solve complex technical problems. (experience)
• Experience with extrusion, laser cutting, laser welding, fluoropolymer processing, thermoplastics, thermosets, and Nitinol (NiTi) processing. (experience)
• Ability to design and fabricate precise tooling utilizing metal and plastic materials. (experience)
• Experience operating and maintaining additive manufacturing equipment and 3D printing technologies. (experience)
• Demonstrated ability to create novel device concepts and platforms from the ground up. (experience)
• Proficiency with SolidWorks and Creo/ProE CAD software. (experience)
• Ability to work independently with minimal supervision in a fast-paced development environment. (experience)
• Strong communication, documentation, and organizational skills. (experience)
• Medical device experience supporting structural heart, transcatheter, catheter-based, or implantable technologies is a huge plus (experience)
• Knowledge of medical device design controls, quality systems, and engineering change processes. (experience)
• Experience managing project expenses, purchase orders, and invoice approvals. (experience)
• Demonstrated ability to work effectively across multidisciplinary teams. (experience)
• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $81,000 to $114,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. (experience)

Responsibilities

• Serve as a subject matter expert (SME) providing broad engineering support across testing, checkout, modification, fabrication, and assembly activities while identifying opportunities for technical improvements and solutions.
• Partner closely with R&D engineers throughout the design and development process.
• Brainstorm, evaluate, and translate concepts into new product designs.
• Apply mechanical engineering principles to delivery systems, implants, and accessory device development.
• Design, build, and fabricate complex prototypes, sub-assemblies, fixtures, and tooling.
• Utilize rapid prototyping techniques for metal and plastic components.
• Build prototypes for feasibility testing and physician demonstrations.
• Recommend materials and manufacturing approaches for prototypes and product designs.
• Perform feasibility, operational, design verification, animal, and cadaver testing.
• Develop, validate, and execute test methods, protocols, and procedures.
• Characterize device performance against design requirements and specifications.
• Identify failure modes, perform root cause analysis, and implement corrective solutions.
• Collect, document, analyze, and communicate test data and results.
• Perform precision measurement and testing utilizing calipers, micrometers, microscopes, optical systems, tensile testers, and inspection fixtures.
• Operate, set up, maintain, and support calibration of laboratory equipment.
• Create and maintain design documentation, drawings, test reports, procedures, and engineering records in accordance with quality system requirements.
• Apply Design for Manufacturing (DFM) and Design for Automation (DFA) principles during development activities.
• Support manufacturing and operations through process development, tooling support, troubleshooting, and training.
• Train and mentor assemblers, contractors, and junior employees.
• Collaborate cross-functionally with R&D, Manufacturing, and Quality teams to ensure compliance with internal procedures and protocols.
• Read, interpret, create, and modify CAD models and technical drawings.
• Maintain compliance with quality systems, laboratory procedures, and safety requirements.
• Independently solve complex technical and engineering challenges.
• Perform general laboratory support activities, equipment maintenance, and organizational tasks as needed.
• Serve as a subject matter expert (SME) providing broad engineering support across testing, checkout, modification, fabrication, and assembly activities while identifying opportunities for technical improvements and solutions.
• Partner closely with R&D engineers throughout the design and development process.
• Brainstorm, evaluate, and translate concepts into new product designs.
• Apply mechanical engineering principles to delivery systems, implants, and accessory device development.
• Design, build, and fabricate complex prototypes, sub-assemblies, fixtures, and tooling.
• Utilize rapid prototyping techniques for metal and plastic components.
• Build prototypes for feasibility testing and physician demonstrations.
• Recommend materials and manufacturing approaches for prototypes and product designs.
• Perform feasibility, operational, design verification, animal, and cadaver testing.
• Develop, validate, and execute test methods, protocols, and procedures.
• Characterize device performance against design requirements and specifications.
• Identify failure modes, perform root cause analysis, and implement corrective solutions.
• Collect, document, analyze, and communicate test data and results.
• Perform precision measurement and testing utilizing calipers, micrometers, microscopes, optical systems, tensile testers, and inspection fixtures.
• Operate, set up, maintain, and support calibration of laboratory equipment.
• Create and maintain design documentation, drawings, test reports, procedures, and engineering records in accordance with quality system requirements.
• Apply Design for Manufacturing (DFM) and Design for Automation (DFA) principles during development activities.
• Support manufacturing and operations through process development, tooling support, troubleshooting, and training.
• Train and mentor assemblers, contractors, and junior employees.
• Collaborate cross-functionally with R&D, Manufacturing, and Quality teams to ensure compliance with internal procedures and protocols.
• Read, interpret, create, and modify CAD models and technical drawings.
• Maintain compliance with quality systems, laboratory procedures, and safety requirements.
• Independently solve complex technical and engineering challenges.
• Perform general laboratory support activities, equipment maintenance, and organizational tasks as needed.

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