Engineer

Description:

Generis Tek Inc is seeking an experienced R&D Engineer for a contract role at their client site in St. Paul, MN. The position involves providing security engineering support for the creation and development of new medical device products, both invasive and non-invasive. The engineer ensures compliance with corporate and divisional policies and procedures, and contributes to all aspects of cybersecurity throughout the product development lifecycle.

Key responsibilities include researching, developing, designing, and evaluating mechanical and electro-mechanical materials, components, assemblies, processes, and equipment. The role also includes conducting cybersecurity testing and validation activities, developing new concepts from initial design to market release, and utilizing product development software to work on embedded systems for electrophysiology products.

The engineer will assess cybersecurity risks of new products and features, perform threat modeling and risk management activities, stay updated on cybersecurity trends, and manage appropriate responses. Collaboration is essential with Systems, Electrical, Software, Quality, Regulatory, and Manufacturing teams to ensure all cybersecurity deliverables comply with FDA and other regulatory requirements. The position also involves using cybersecurity frameworks, planning security activities such as penetration testing, and standardizing security functions across product development.

Basic Qualifications:

• Bachelor’s degree in Software Engineering, Computer Engineering, Computer Science, or related field (Master’s preferred)

• Hands-on experience in software development within regulated medical environments

• Proficiency in threat modeling (STRIDE) and cybersecurity activities

• Strong knowledge of cybersecurity architecture, design, implementation, concepts, and technologies

• Experience with security frameworks such as NIST, OWASP, ISO

• Familiarity with global medical device regulations including FDA, EU-MDR, CFDA

• Experience in information security risk management, compliance, platform security, network security, cloud security, application security, or embedded device security

• Knowledge of visual modeling/design, multi-threading, formal software development methodologies, and source code management

• Experience working in iterative agile development processes

Preferred Qualifications:

• Master’s degree in software engineering, computer engineering, or computer science

About the Organization:
Generis Tek Inc provides talent and solutions for engineering and technical projects across industries. This contract opportunity places the engineer at a medical device technology center in St. Paul, MN, contributing to cutting-edge medical technology development.