Job Description

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

About This Role:

As a Senior Systems Engineer, you will lead systems engineering activities for medical device development programs. This role ensures user needs, clinical requirements, and regulatory guidelines are translated into robust, verifiable design inputs. You will provide technical leadership, mentor junior engineers, and collaborate across multi-disciplinary teams to deliver safe, effective, and compliant medical devices.

What You Will Do:

• Lead system engineering tasks and deliverables for medical device development projects.
• Drive identification and development of design input requirements aligned with FDA, ISO 13485, and IEC standards.
• Collaborate with user research specialists and clinical experts to gather and prioritize stakeholder needs.
• Provide technical and tactical leadership to cross-functional teams, ensuring compliance with design controls and risk management processes.
• Train and mentor new and less experienced engineers on systems engineering best practices.
• Participate in continuous improvement initiatives to enhance systems engineering methodologies and tools.
• Support business development activities by engaging with potential clients and providing technical insights.

Qualifications
Required:
• Bachelor’s degree in engineering or related discipline.
• 3–6 years of relevant work experience in medical device systems engineering or a regulated industry
• Strong knowledge of systems engineering principles and medical device product development lifecycle, including verification and validation
• Familiarity with regulatory requirements (FDA, IEC 60601, ISO 14971) and design control processes.
• Excellent written and oral communication skills.
• Ability to manage multiple projects under strict timelines and solve moderate to complex technical problems
• Ability to lead and coordinate small cross-functional teams
Preferred:
• Master’s degree in engineering or related discipline.
• Experience with risk management and usability engineering for medical devices.
• Knowledge of advanced systems modeling tools and methodologies.

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.