Medical Device Design And Development Project Manager

Overview

Endo-Therapeutics, Inc. is a leader in designing, developing, and manufacturing high-quality single-use instruments for endoscopy. Our products, such as biopsy forceps and polypectomy snares, are trusted by hospitals and surgery centers worldwide. We also specialize in contract and private label manufacturing, supporting customized medical device needs. Our commitment to innovation and quality has earned us a strong reputation in the healthcare industry.

Purpose of the Position:

The Medical Device Design & Development Project Manager is responsible for the overall planning, coordination, execution, monitoring, and successful completion of medical device development projects from concept through production. This role ensures projects are delivered on time, within scope and budget, and in full compliance with company objectives, quality systems, and applicable regulatory requirements.

Key Responsibilities:

• Lead end-to-end planning and execution of medical device design and development projects.
• Define project scope, objectives, deliverables, timelines, and success criteria in collaboration with cross-functional stakeholders.
• Develop and maintain detailed project plans, schedules, and resource allocations.
• Coordinate cross-functional teams including Engineering, Quality, Regulatory, Manufacturing, and Operations.
• Manage project budgets, forecasts, cost controls, and resource planning.
• Oversee product testing, validation, inspection, and logistics activities to ensure product quality and timely delivery.
• Ensure compliance with internal quality systems, design controls, and regulatory requirements (FDA, ISO 13485, EU MDR, etc.).
• Monitor project progress, identify risks, and implement mitigation strategies.
• Manage project changes through formal change control processes.
• Communicate project status, risks, and milestones to senior leadership and stakeholders.
• Conduct lessons learned and post-project evaluations to support continuous improvement.

Experience

Required:

• Mid- to senior-level project management experience in a regulated industry (medical device experience strongly preferred).
• Proven ability to lead cross-functional teams in a technical or engineering environment.
• Experience managing project schedules, budgets, risk assessments, and change control processes.
• Experience with product development lifecycle in medical device or pharmaceutical manufacturing environments.
• Strong leadership, organizational, and communication skills.
• Proficiency in project management tools (MS Project, Smartsheet, Jira, or equivalent).
• Experience with inspection, quality control, logistics coordination, and expediting activities.
• Strong problem-solving, decision-making, and risk management capabilities.
• Ability to manage multiple projects and priorities in a fast-paced, regulated environment.

Education:

• Bachelor’s degree in Engineering, Project Management, or related field (preferred).

Quality Objectives:

• Ensure all projects adhere to internal quality system procedures and design control requirements.
• Maintain compliance with domestic and international regulatory standards governing medical device development.
• Support documentation, risk management, and regulatory submissions throughout the project lifecycle.