Principal Engineer

PRINCIPAL ENGINEER:

The Principal Systems Engineer will oversee the design, development, and regulatory submission of a novel, oncology-focused, implantable physiologic monitor. This role requires in-person work at our engineering facility in Foxborough, MA. Primary responsibilities include collaborating with external electrical, mechanical, and software development partners, managing verification and validation testing, and generating design documentation including risk management files.

Veris Health is focused on delivering enhanced personalized cancer care through remote patient monitoring using a digital health platform and connected devices. The platform seeks to offer enhanced personalized cancer care through the early detection of complications, reduced unplanned hospitalizations, the provision of longitudinal trends of physiological and clinical data, data-driven risk management tools, and increased patient and provider satisfaction. Veris is developing an implantable physiological monitor, designed to be implanted in combination with a vascular access port, which will interface with the Veris Cancer Care Platform and includes sensing capabilities for continuous cardiac monitoring, step count, temperature, and respiratory rate. The implantable monitor will further enhance the clinical and commercial value of the platform by providing remote physiologic data independent of patient compliance. We're seeking a Principal System Engineer to act as technical lead through development and clearance of the first implantable physiological monitor designed for oncology patients.

JOB RESPONSIBILITIES:

• Technical Leadership and Decision-Making: Lead project technical execution through the remaining phases of product development, including design and development, verification and validation, and design transfer. Provide advanced technical guidance to engineering teams (both internal and external) to navigate key development activities efficiently. Act as a key technical decision-maker throughout product development.
• Risk Management and Design Control: Lead and implement comprehensive risk management activities, ensuring design controls are fully implemented. Ensure all risk mitigation strategies are adequate and appropriately integrated into product design. Ensure the design and processes are well-documented and compliant with regulatory standards.
• Verification and Validation Testing: Lead the development of comprehensive validation plans and test protocols. Manage verification and validation activities, including vendor and test house management, to ensure that all testing meets regulatory requirements and ensures the safety and efficacy of the device.
• Mentorship and Leadership: Provide mentorship and technical leadership to junior engineers, ensuring they follow best practices in design, testing, and documentation. Promote a collaborative environment that fosters knowledge sharing, skill development, and continuous growth.
• Communication: Provide regular updates on development progress to senior management. Collaborate with project management to ensure alignment across teams on timelines, deliverables, and objectives.
• Cross-Functional Collaboration and Regulatory Submission: Work closely with regulatory and quality teams to ensure compliance with quality management system and regulatory requirements. Own the creation and compilation of engineering documentation required for regulatory submission (e.g., 510(k)).

JOB REQUIREMENTS:

• Education: Bachelor's Degree in Engineering or a related scientific field required. Master's Degree in Engineering or an MBA preferred.
• Experience & Technical Expertise: Minimum 10 years of experience in product development in the medical device industry, specifically with FDA-regulated Class II or III devices. Proven success in leading electronic device development from early concept to regulatory clearance and commercialization. Experience with active implantable devices, specifically Insertable Cardiac Monitors (ICMs), is highly preferred.
• Problem Solving and Decision Making: Strong analytical thinking and problem-solving abilities with a proven track record of making data-driven decisions. Ability to manage complex project risks and resolve engineering challenges with minimal oversight, while maintaining a clear focus on timelines and regulatory milestones.
• Communication and Collaboration: Effective written and verbal communication skills with the ability to convey technical information to diverse audiences, including technical and non-technical stakeholders. Strong team player with the ability to work effectively with cross-functional teams and senior leadership.
• Travel: Occasional travel will be required to visit venders / development partners, attend meetings, and oversee testing.

PAVmed Inc. and its subsidiaries are committed to creating a diverse work environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are also committed to compliance with all fair employment practices regarding citizenship and immigration status.