Senior System Verification Engineer (Medical Devices)

Job Summary

Our success comes from our Velico® Team who are global thinking (to save many lives worldwide), visionary (as we are future focused industry leaders, collaborative (we deliver the best results through inclusion and diversity), professional (as are our highly qualified team of experts) and honorable (we work ethically and look to do the right thing). We seek like-minded individuals to join us. Velico’s® mission is to eliminate preventable death from bleeding. This is a rare opportunity to contribute to a true innovation in transfusion medicine and trauma care, that could result in saving thousands of lives each year.

Based in Beverly, MA we are seeking a highly-motivated person who wants to support an organization who is involved in groundbreaking technology with the skills, education & experience needed. We are seeking an individual who will be responsible for ensuring the quality and safety of our medical devices including developing, executing, and leading comprehensive verification plans for complex medical device systems so that they meet all regulatory requirements and deliver optimal performance.

Responsibilities include:

• Leads the development and execution of system verification plans for medical devices, ensuring compliance with all relevant regulations (e.g., FDA, IEC 61010, ISO 14971, IEC 62304).
• Analyze system requirements and translate them into test protocols.
• Designs and implements test strategies and methodologies for various system components and functionalities across the Software, Hardware, and Systems levels.
• Develops and maintains automated test scripts using appropriate tools and languages (e.g., Python, C++, test frameworks).
• Performs manual testing and analysis to identify and document potential issues and defects.
• Coordinates with project management on verification timelines and readiness.
• Collaborates effectively with cross-functional teams (e.g., engineering, software, quality) to resolve identified issues and ensure timely closure.
• Participates in risk assessments and failure mode analysis (FMEA) to identify and mitigate potential risks.
• Maintains accurate and complete documentation of all verification activities, including test plans, reports, and defect tracking.
• Contributes to engineering discussions regarding design for testability, maintainability, and quality.
• Ensures alignment of internal and external customers.
• All other duties, as assigned.

We are seeking individuals with:

• Bachelor’s of Science degree BS in Biomedical/Mechanical Engineering or directly related scientific discipline, MS preferred.
• Applied understanding of mechanical, electromechanical, and systems design.
• 5+ years of experience in medical device system engineering or a related role.
• Solid understanding of medical device regulations and standards (e.g., FDA QSR, ISO 13485, IEC 60601).
• Proficiency in system-level design, requirements management, and architectural development.
• Excellent working knowledge of computer systems including MS Office Suites with advanced knowledge of Excel.

Interested candidates are to have:

• Adept at researching and incorporating new technologies, materials, and methods and effectively documenting information.
• Manages vendors effectively.
• Understands and resolves interdisciplinary engineering challenges and constraints.
• Conducts effective design reviews and demonstrates critical attention to detail.
• Excellent verbal and written English communication and presentation skills.
• Critical thinking and problem-solving skills including identifying, recommending and implementation of solutions.
• Required to work cross-functionally within the organization and with external customers and vendors.
• Self-directed and proven skill to work independently, as well as part of a team.
• Ensures work is completed in the expected timelines and is adept at resolving competing priorities.
• Results-oriented with strong analytical skills and exercises appropriate judgment and make decisions based on accurate and timely information.
• Possesses a high level of integrity and dependability with a strong work ethic.
• Maintains a high level of confidentiality.
• Process and improvement focused on implementing new procedures to accommodate growth and adaptable to change priorities, as needed.
• Demonstrates exceptional interpersonal skills and fosters strong working relationships and is adept at interacting with diverse groups of people, as well as conflict resolution.
• Self-motivated to work efficiently in a team-oriented environment with a high degree of multi-tasking and prioritizing multiple projects/tasks meeting expected deadlines.
• Promotes and fosters a positive behaviour and work environment.
• Comfortable working in a fast-paced, entrepreneurial company environment.
• Excellent working knowledge of computer systems including MS Office Suites with advanced knowledge of Excel.

Hybrid position, with work in our Beverly, MA office expected 3-4 days per week.

Work is usually performed in a sitting position and may require stooping, kneeling, reaching, lifting and carrying during the course of the work shift. Required to solely lift and safely move material of up to approximately 25 lbs. during the course of the work shift.

May be required to work nights or weekends to meet monthly, quarterly and/or annual compliance deadlines.

May require traveling up to 33% of the time via car and air in the U.S. and abroad.

Interested candidates are to send their resume, cover letter and salary requirements.