Sr Design Readiness Engineer - Ampcus Incorporated

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 Design Readiness Engineer

Location(s): Newton, MA

• The Senior Design Readiness 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 highly visible technical resource working on the transition of complex electro-mechanical assemblies from prototype to verification builds and testing, in close collaboration with manufacturing engineering.
• This role is suited for an R&D engineer with experience in developing, building, and testing complex electro-mechanical medical devices, design transfer, and process validation with broad knowledge of mechanical, mechatronics, firmware, software, and systems engineering, including design verification testing, and transfer to manufacturing within a regulated medical device development environment.

• Being a key team member working on design readiness of the robotic system.
• Support development of assembly and test processes.
• Support identification of, specification creation for, development and characterization of in-line test and build fixtures.
• Support development and maintenance of the BOM and DMR.
• Specify firmware and software development requirements for test and build fixtures.
• Author relevant documents such as build process, assembly instructions, inspection procedures, test protocols, test reports, analyses, and system documentation.
• Support a variety of multi-disciplinary technical and process improvement projects of different sizes and scopes.
• Help with the vendor communications and procurement issues.
• Support creation of DHF and release of documentation to quality system.
• Manage and communicate assigned projects in collaboration with cross-functional teams.

• 8+ years electromechanical R&D engineering experience, at least 5 years in medical device required.
• Bachelor’s degree in Mechanical/ Robotics/ Mechatronics/Advanced Manufacturing. Engineering or a close field is required.
• Deep understanding of DFM (Design for Manufacturing), DFA (Design for Assembly), and DFT (Design for testing) required.
• Experience in managing engineering projects required.
• Expertise with firmware and software within electromechanical systems is highly desired.
• Knowledge of PCBAs (understanding the design, testing, and documentation) is highly desired.
• Must have previous experience in design transfer/new product introduction.
• Must have in-depth knowledge of design verification of complex medical devices.
• Must have deep knowledge and working experience of medical device design control.
• In-depth knowledge and experience in transferring design to manufacturing is required.
• Experience in off-the shelf component selection for regulated industries highly desired.
• Experience with statistical tools and software such as Minitab and MATLAB desired.
• Able to execute assigned projects and duties with minimal supervision.
• Outstanding documentation and communication skills required.
• Proficiency in using MS Office and Solidworks 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.