Project Engineer / Program Manager Medical Devices

Overview We are seeking a Program Manager (Project Engineer) to lead innovative medical device projects from concept through commercial launch. This role blends engineering expertise with program management skills to deliver safe, effective, and compliant products - on time, within budget, and to the highest quality standards.

Key Responsibilities

• Lead cross-functional teams (R&D, Quality, Regulatory, Manufacturing) through the full product lifecycle in compliance with ISO 13485 and FDA design controls .

• Develop and manage project plans, budgets, schedules, and risk registers .

• Facilitate design reviews, technical problem-solving, and product verification/validation activities.

• Ensure adherence to regulatory and quality requirements , preparing documentation for regulatory submissions.

• Monitor progress, manage risks, and present updates and solutions to stakeholders.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Electrical, or related engineering discipline ( Master's preferred ).

• 5+ years of experience in medical device development, including 3+ years in program or project management.

• Strong knowledge of design controls , risk management (ISO 14971) , and global regulatory standards.

• Proficiency in project management tools such as MS Project, Smartsheet, or Jira .

• Exceptional leadership, communication, and analytical problem-solving skills.