R&D Engineer II (Systems Engineering)

Description

The primary focus of this R&D Engineer II role is to apply a systems-thinking approach to perform risk management activities, develop design input requirements, and establish traceability between design inputs and design outputs throughout the product development lifecycle of the WiSE CRT System. They will contribute to the implementation of an application lifecycle management (ALM) tool to manage requirements, risks, hazard analysis, and verification testing. The engineer will develop a strong understanding of the current design technology and will be involved in new product development projects to establish high quality risk documentation and conduct change impact assessments. This multidisciplinary role interfaces with many parts of the company including quality assurance, regulatory affairs, clinical, and other engineers.

The ideal candidate is a quality-focused self-starter with high attention to detail who thrives in a small, fast-paced environment. They have strong communication skills, sense of responsibility, and drive for continuous improvement and professional growth. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market and expand existing products globally. 

Essential Duties and Responsibilities

• Develop and maintain risk management files (e.g. risk management plan, risk analysis, risk reports) in accordance with ISO 14971 and applicable regulatory standards.
• Conduct system-level hazard analysis and failure modes and effects analyses (FMEA/FMECA) for the current design technology and new product development projects.
• Facilitate the implementation of the application lifecycle management (ALM) tool JAMA to manage traceability between design inputs, design outputs, and design verification.
• Develop requirements based on clinical and engineering inputs, applicable standards, and regulatory authority guidance documents. 
• Establish and maintain traceability matrices linking user needs, system requirements, subsystem requirements, verification test methods, verification plans, and verification testing results.
• Collaborate with cross-functional teams including project managers, engineering, quality assurance, clinical, and regulatory affairs to develop a thorough understanding of system risks and mitigations.
• Assess the impact of proposed product design changes to requirements, risks, and verification to determine appropriate updates to traceability, regression testing, and documentation.
• Support design reviews, risk assessments, and requirements reviews throughout the product development lifecycle from concept through post-market surveillance.
• Author design history file (DHF) deliverables and reports in accordance with internal quality system procedures and external regulatory expectations.
• Support product development efforts, design verification, and validation processes.
• Participate in post-market risk evaluations and support the resolution of product complaints, non-conformances, and corrective and preventive actions (CAPA).

Other Duties and Responsibilities

• Initiate document change orders (DCO) in the quality management system (QMS).
• Support internal and external audits as required.
• Support company goals and objectives, policies, and procedures.
• Comply with design control practices, standards, and regulations.
• Other duties as assigned. 

Education and Required Experience

• Minimum BS degree or equivalent in biomedical, systems, mechanical, electrical, or related engineering discipline.
• Minimum 2 years of experience in systems, R&D, quality engineering or related field developing commercial medical products. 

Knowledge, Skills, and Abilities

• Experience performing risk management activities and hazard analysis per ISO 14971.
• Experience establishing traceability between requirements, risks, and verification.
• Experience with medical device product development lifecycle and design controls per ISO 13485 and FDA 21 CFR 820.
• Experience authoring reports and technical documentation to support design reviews and Design History File (DHF) deliverables.
• Experience with application lifecycle management (ALM) tools such as JAMA or Helix.
• Strong interpersonal skills to effectively collaborate with cross-functional teams and stakeholders.
• Strong verbal and written communication skills; ability to generate clear and concise documentation and explain complex concepts at different technical levels.
• Detail-oriented and quality-focused with strong problem-solving abilities.
• Flexible and quick to adapt