◈ 직무 개요

- Frequently interact with Software Engineering, Software Test, Embedded Systems, Quality Engineering/Assurance and broader project team members to drive the test process into the software/system design for each sprint.
- Advise the team on technical and business risks, standards requirements and open issues related to the software quality process and associated documentation.
- Coordinate efforts with cross-functional team to ensure compliance of design controls and risk management activities for new medical device software, by following the governing standards.
- Initiate and drive SW Risk Management activities and draft SW Risk Management documentation, swFMEAs and other SW related items working together with Software Engineering and Embedded Systems teams.
- Assist with the draft and review of product and software requirements, engineering designs, user documentation and software verification plans, protocols and reports.
- Provide traceability back to the system/hazard/risk requirements.
- Coordinate and release software risk analysis documents.
- Review and interpret the results generated from software testing including static analysis, runtime analysis, and/or code reviews.
- Assess both the safety risk and security risk for the OTS/SOUP used in the product software.
- Conduct OTS/SOUP analysis and generate BASIC DOCUMENTATION and/or SPECIAL DOCUMENTATION per FDA guidance.
- Review System/Software Architecture and Design documents.
- Review FDA cybersecurity related documents and coordinate testing.
- Collaborate with R&D, Quality and Regulatory Teams to develop and execute SWQA activities to meet commercial milestones in an agile software development environment.

◈ 경력 요건

- Working knowledge of design controls, risk management/analysis, and to the listed external software standards applicable to complex medical device products.
- Proficient in common safety risk analysis techniques: FMECA (Failure Mode, Effects and Criticality Analysis), FTA (Fault Tree Analysis), FFA (Functional Failure Analysis) or related.
- Experience with software development tools, including requirements management systems, system/software architecture tools, software configuration/version control tools, analysis and bug-tracking database.
- Capable of using defect tracking systems like JIRA and Confluence
- Working knowledge of SW risk control measures (e.g., Monitoring, Segregation, etc.)
- Understanding of cybersecurity design approaches and verification/vulnerability testing
- Comfortable and effective in a startup environment.
- This position requires established verbal, written (English) and interpersonal communications skills with proven ability to translate technical information into effective procedures, plans, specifications and agreements.
- Ability to effectively present information in one-on-one and small group situations to supplier personnel, partners, consultants and employees at all levels of the organization.
- Detail oriented with the ability to define problems, collect data, establish facts, and draw valid logical and/or statistical conclusions.
- Ability to read and interpret software code in C++ required.
- Excellent project and time management skills.

Preferred Skills/Abilities
- Experience with complex systems.
- Experience with requirements management systems (JAMA, DOORS, Requisite Pro, etc.).
- Basic understanding of Real-time Operating System (RTOS), Network Infrastructure and Security, Robotic Controls and/or Embedded Software.
- Knowledge of security risk analysis standards and techniques (including UL 2900 series, AAMI TIR 57, NIST Cybersecurity Framework, Threat Modeling, Penetration Testing, etc.) will be a plus.
- RAC (Regulatory Affairs Certification) or equivalent certification.
- Proven track record of successful regulatory submissions and product approvals.
- In-depth understanding of FDA regulations, EU MDR, ISO 13485, and other relevant global regulatory frameworks.
Education and Experience
- Bachelor’s degree or advanced in Computer Science, CSEE, Software Engineering or a related field.
- Minimum of 5 years of experience in a software quality, design or test role performing planning, documentation and risk analysis/reduction activities in the medical device or comparable regulated industry.
- Working knowledge of Software Risk Management, Design Controls and to the listed External Software Standards applicable to complex medical device products.

◈ 제출 서류 및 기타

- 영문 이력서 및 자기소개서

◈ 담당 컨설턴트

- 이건교 / 02-2016-6602 / [email protected]