Sr. Manufacturing Fixture Design Engineer

Ampcus, Inc
United States, Massachusetts, Newton
Dec 19, 2024
Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team. Job Title: Sr. Manufacturing Fixture Design Engineer Location(s): Newton, MA Company Background: Endovascular Robotics (EVR) division, is a global technology leader in robotic-assisted vascular interventions. The company's CorPath system is the first FDA-cleared medical device to bring robotic-assisted precision to neurovascular, percutaneous coronary and peripheral interventions. EVR is advancing the field of interventional medicine with robotics through improvements to procedural control, precision, and workflow. Position Summary: The Senior Manufacturing Fixture Design Engineer will be a part of the R&D organization and an important contributor to the realization of the next generation robotic platform that will change the future of healthcare. You will be a visible technical resource working on the transition of complex electro-mechanical assemblies from prototype to verification testing and pilot builds, in close collaboration with manufacturing engineering. This role is suited for an R&D engineer with experience in developing build and test fixtures for complex electro-mechanical medical devices and disposables. A broad knowledge of mechanical design, DFA/DFM, including design verification testing, process validation, and transfer to manufacturing within a regulated medical device development environment. Key Responsibilities: Being a key team member working on the design readiness of a robotic surgical platform. Design and develop production build and test fixtures for complex electromechanical sub-systems for production volumes. Create fixture requirements, design descriptions, use and preventive maintenance documentation. Perform fixture qualifications and verifications in conjunction with Quality and Manufacturing Engineering. Support development of assembly and test processes for capital equipment and disposables. Develop fixtures and tests for component inspection. Support a variety of multi-disciplinary technical and process improvement projects of different sizes and scopes. Create engineering changes orders for the release of fixtures and tooling documentation. Manage and communicate assigned projects in collaboration with cross-functional teams. Qualifications: 8+ years electromechanical and consumable R&D engineering experience, at least 5 years in medical device required. Bachelor's degree in Mechanical/ Robotics/Advanced Manufacturing Engineering is required. Must have strong Solidworks/PDM proficiency. Deep understanding of DFM (Design for Manufacturing), DFA (Design for Assembly), and DFT (Design for testing) required. Experience in the design, qualification, and verification of fixtures for medical devices assembly and test is required. Expertise with electromechanical system development is highly desired. Experience in developing Simulink-based fixture is required. Proficiency in Simulink/LabVIEW is desired. Must have previous experience in design transfer/new product introduction. Experienced in fixture and process validation. Experience with statistical tools and software such as Minitab desired. Able to execute assigned projects and duties with minimal supervision. Outstanding documentation and communication skills required. Proficiency in using MS Office required. Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.