Principal Medical Device Engineer

Principal Medical Device Engineer

Position Overview
We are seeking a highly experienced and strategic Principal Medical Device Engineer to lead the ideation, assessment, and development of innovative drug delivery technologies and medical devices. This role combines technical leadership, hands-on engineering expertise, and cross-functional collaboration to drive product development from concept through commercialization. The ideal candidate will play a critical role in shaping long-term technical strategy while ensuring compliance with global regulatory and quality standards.

Key Responsibilities

• Lead the design and development of new and enhanced medical devices, ensuring alignment with user needs, regulatory requirements, and quality standards.
• Drive innovation and R&D initiatives to develop and improve drug delivery systems, contributing to strategic decision-making.
• Oversee design verification and validation activities to ensure product safety, effectiveness, and performance.
• Provide technical leadership and mentorship to junior engineers and cross-functional teams.
• Manage project timelines, budgets, and resources to ensure successful and cost-effective delivery.
• Support regulatory submissions by contributing to IND/NDA responses and ensuring compliance with applicable standards and guidelines.
• Ensure adherence to design control requirements, including 21 CFR Part 820, 21 CFR Part 4 (Combination Products), ISO 13485, ISO 14971, and IEC 62366.
• Develop and maintain Design History Files (DHFs) and ensure compliance throughout the product lifecycle.
• Collaborate with Manufacturing, Quality, Regulatory, Clinical, Human Factors, and other stakeholders to define requirements and ensure product success.
• Conduct risk assessments (FMEA, user risk analysis) and implement mitigation strategies.
• Identify and evaluate new technologies, materials, and testing methodologies.
• Analyze data from testing and manufacturing processes to drive continuous improvement.
• Lead change management initiatives for existing products to maintain compliance and minimize operational impact.
• Manage external partners including manufacturers, testing labs, and consultants.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 15+ years of experience in medical device design, development, and testing.
• 5+ years of experience in combination product development (injectables or ophthalmic preferred).
• Proven experience across the full product lifecycle, from concept to commercialization.
• Strong knowledge of regulatory standards including 21 CFR Parts 4 & 820, ISO 13485, ISO 14971, and IEC 62366.
• Experience creating and managing DHFs and supporting regulatory submissions.
• Demonstrated leadership experience, including mentoring engineers and leading cross-functional teams.
• Proficiency in project management tools (Gantt charts, PMP certification preferred).
• Hands-on experience with CAD tools, materials science, tolerance analysis, and drafting standards.
• Experience with human factors engineering and usability validation.
• Strong analytical skills, including statistical analysis and Measurement System Analysis (MSA).
• Six Sigma Green Belt or equivalent certification is a plus.
• Excellent communication, problem-solving, and collaboration skills.

Preferred Experience

• Experience in parenteral drug-device combination products.
• Background in developing novel testing methods for medical devices.
• Strong exposure to global regulatory environments and submissions.