Senior Engineering Specialist

Job Title: Senior Engineering Specialist

About the Role

We are seeking a highly skilled and motivated R&D Technical Lead to join our team developing innovative medical products and technologies. This role combines technical leadership, systems engineering, and regulatory compliance responsibilities, guiding cross-functional teams through the full product lifecycle—from concept development to commercialization and post-market support.

The R&D Technical Lead plays a critical role in driving innovation and excellence in the development of cutting-edge medical products and technologies. This position blends deep technical expertise with leadership and systems engineering, guiding cross-functional teams through every stage of the product lifecycle—from initial concept and design to commercialization and post-market support.

The role demands a strong understanding of regulatory compliance, ensuring that all documentation and traceability requirements are met for successful submissions. With a focus on shaping product architecture and defining system and sub-system requirements, the Tech Lead is instrumental in delivering safe, effective, and transformative healthcare solutions.

In this dynamic and regulated environment, the Tech Lead also serves as a mentor and technical authority, fostering growth and collaboration across engineering teams. Their influence extends beyond technical execution, helping to cultivate a culture of innovation and continuous improvement.

By aligning engineering efforts with strategic goals, they ensure that the organization remains at the forefront of medical technology development.

Main Responsibilities

• System Design & Development: Lead system-level design and development for new and existing medical products, ensuring alignment with stakeholder needs.
• Requirements & Architecture: Define product architectures and translate stakeholder inputs into clear, traceable system requirements.
• Integration & Testing: Oversee system integration and testing activities, supporting verification and validation across hardware, software, UX, and systems.
• Technical Leadership: Provide mentorship and technical guidance to cross-functional teams, promoting engineering excellence.
• Documentation & Tools: Own and maintain design control documentation, SOPs, and requirements using tools like DOORS and Modern Requirements. Lead configuration/change control processes (e.g., CCB, CIT) and find opportunities for development optimization.
• Regulatory Compliance: Ensure compliance with ISO 13485, ISO 14971, FDA QSR, and support FDA submissions through collaboration with quality and regulatory teams.
• Risk Management: Conduct risk assessments and implement mitigation strategies, contributing to activities like dFMEA and hazard analysis.
• Multi-functional Collaboration: Work closely with Engineering, Quality, Regulatory, Manufacturing, and Marketing to ensure smooth project execution and post-market support.
• Project Execution & Tools Development: Develop project plans, technical documents, and Excel-based toolsets to streamline workflows and support design control processes.

Required Skills and Qualifications

• Bachelor's or Master's degree in Engineering, Systems Engineering, Biomedical Engineering, or related field.
• 5+ years of progressive experience as a senior/lead engineer in product development.
• Creative problem solver with the ability to resolve conflicting requirements and technical risks.
• Practical experience in configuration management and change control processes.
• Familiarity with tools like DOORS, Modern Requirements, SolidWorks, MATLAB, LabVIEW, Minitab.

Preferred Qualifications

• Certification in regulatory compliance or related field.
• Experience in leading cross-functional teams and collaborating with stakeholders.