Systems Engineer – Medical Robotics & NPI

Corin Group; Raynham (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Systems engineering

Requirements management

Risk management

MBSE

Cybersecurity

CAPA

Regulatory awareness

Cross-functional collaboration

Education

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

Tools

Jama

Doors

Windchill

Job description

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.