System Engineer

Corin Group; Raynham (MA); Presencial; USD 100 000 - 140 000; Tempo integral

Resumo da oferta

Corin Group is seeking a Systems Engineer to develop NPI medical devices, integrating hardware, software/firmware and instrumentation for orthopaedics within the Corin Ecosystem.

You will drive system-level design, compile and maintain design history files, perform risk management and verification activities, collaborate with cross-functional teams, and support global market submissions while adhering to ISO13485 and GMP requirements.

Qualificações

• University degree in Mechanical Engineering, Biomedical Engineering, Product Design, or equivalent.
• Experience with requirements management software (Jama, Doors, Windchill).
• Experience with systems engineering principles and/or MBSE.
• Previous work experience in a regulated medical devices industry.
• Knowledge of the CAPA process and related problem-solving techniques.
• Experience with Cybersecurity, ISO14971, IEC60601, ISO62366 is highly regarded.

Responsabilidades

• Define, maintain and drive the technical file development from a system perspective for technology products including DHF, Risk Management File and Usability File to meet standards.
• Apply systems engineering best practices across the portfolio, including requirements management, risk management, verification and validation planning, and lifecycle support.
• Contribute to intended use definitions, use cases, and end-to-end traceability across product and system requirements.
• Define and understand system-level architecture, data flows, and interactions between sub-systems (software, hardware, instrumentation, electronics).
• Evaluate system-level risks and design decisions to align with customer needs and business objectives.
• Collaborate with Sub-system Owners and Technical Project Manager to deliver a system meeting user and stakeholder needs.
• Partner with R&D, Quality, Regulatory Affairs, Manufacturing and Marketing throughout the product lifecycle.
• Support product submissions to global markets including USA, AUS and EU.
• Adhere to QMS requirements per Corin ISO13485 and GMP FDA21 CFR Part 820.
• Ensure CAPA processes meet SOPs and support global CAPA objectives.

Conhecimentos

Systems engineering

Requirements management

Risk management

MBSE

Cybersecurity

CAPA

Regulatory awareness

Cross-functional collaboration

Formação académica

Bachelor's degree in Mechanical/Biomedical Engineering or Product Design

Ferramentas

Jama

Doors

Windchill

Descrição da oferta de emprego

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.

The key responsibilities of the Systems Engineer are to:

• 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

The ideal Systems Engineer will have/be:

• 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)
• Previous work experience in a regulated industry, preferably medical devices.
• Knowledge of the CAPA process and associated problem-solving techniques.
• Experience with Cybersecurity, ISO14971, IEC60601, ISO62366 would be highly regarded

The pay range for this position is $100,000 - $140,000. The specific pay offered may be influenced by a variety of factors, including the candidate’s experience, education, and skill set.

Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.