Development Engineer

Corin•Raynham, MA

1d•Hybrid

About The Position

Corin is hiring for a Development Engineer to work on the development of NPI (New Product Introduction) medical technology devices, hardware and instrumentation for Hip and Knee. The focus is on development of robotic technologies integrated with the Corin Ecosystem. Additionally, the engineer will support already commercialized products by Corin Group through design optimization and maintenance. This position requires you to be on-site in our Raynham, MA facility at least once a week.

Requirements

An advanced Apprenticeship or University degree in relevant subjects such as Mechanical Engineering, Biomedical Engineering, Product Design, or equivalent experience.
A competent CAD operator, with experience with Siemens NX and/or SolidWorks would be an advantage.
Computer literacy.
Good communication skills
Previous work experience in a regulated industry, preferably medical devices.
Knowledge of manufacturing processes and inspection methodology.
Knowledge of the CAPA process and associated problem-solving techniques.
2+ Years of relevant experience

Responsibilities

Create the necessary design documentation to current SOP’s and design procedures.
Structural calculations, tolerance stack analysis, CAD assembly assessment
Validate and verify to support the development process.
Lead the creation and maintenance design and manufacturing documentation for robotic technologies, instrumentation and hardware
Lead the creation and maintenance 3D and 2D CAD drawings and models for design and manufacturing use.
Manage specific design projects as and when required, to budgets and plans.
Lead and participate in project core teams, liaising with QA, RA, Clinical, R&D, Manufacturing, and Production Engineering as part of CAPA, continuous improvement, and optimization projects.
Critical review and updating of Design History File (DHF) and risk management documentation.
Provide design and process support to Corin departments, sub-contractors, and customers.
Produce test protocols and reports to support performance testing of Corin instrument and robotic devices.
Identify areas for process improvements and initiate projects.
Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820
Ensure that process & timeline requirements for Corrective & Preventive Actions (CAPA) are met following Corin’s Standard Operating Procedures (SOPs) and support of Corin’s Global Objectives for CAPA