Systems Engineer

Corin Group•Raynham, MA

33d

About The Position

The System Engineer's key purpose is developing NPI (New Product Introduction) medical technology devices, complex systems of hardware, software/firmware and instrumentation for orthopaedics. 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.

Requirements

University degree in relevant subjects such as Mechanical Engineering, Biomedical Engineering, Product Design, or equivalent experience.
Experience with Requirements management software (e.g Jama, Doors, Windchill)
Experience with systems engineering principles and/or Model Based System’s engineering (MBSE)
Computer literacy.
Good communication skills
Previous work experience in a regulated industry, preferably medical devices.
Knowledge of the CAPA process and associated problem-solving techniques.

Nice To Haves

Experience with Cybersecurity, ISO14971, IEC60601, ISO62366 would be highly regarded

Responsibilities

Define, maintain and drive the technical file development from a system perspective for technology products including critical review and updating of Design History File (DHF), Risk Management File and Usability File to meet international and regulatory standards
Apply systems engineering best practices across the portfolio, contributing to systems activities across the portfolio of Corin Technology Products, including requirements management, risk management, verification and validation planning, and lifecycle support.
Contribute to intended use definitions, use cases, use conditions, stakeholder needs, design inputs, and own end-to-end traceability across product and system requirements.
Define and understand the system level architecture, including data flows through out the system, and interactions between sub-systems (software, hardware, instrumentation, electronics).
Evaluate system-level risks, trade-offs, and design decisions (and their impact on launched products) to ensure alignment with customer needs, product requirements, manufacturing, and business objectives.
Work closely with the Sub-system Owners (Product Owner’s, Business analysts, Hardware engineers) and Technical Project Manager to deliver a system that meets the user/product needs, alongside the stakeholder needs
Partner with Research and Development, Quality, Regulatory Affairs, Manufacturing and Marketing throughout the product lifecycle.
Support product submissions to global markets including but not limited to, USA, AUS and EU.
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