项目工程师

Category: Medical Device

Location:

We are seeking a talented and self-driven Project Manager to lead cross-functional programs within the medical device industry, ensuring projects are executed on time, within scope, and in compliance with regulatory and quality standards. This role requires strong leadership, organizational, and technical acumen to manage complex product development and lifecycle initiatives that support business objectives and patient safety.

The ideal candidate possesses a balance of strategic thinking and executional excellence, with the ability to collaborate across R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams. The Project Manager will be responsible for coordinating all aspects of project planning, execution, risk management, and reporting while ensuring adherence to FDA, ISO 13485, and global medical device regulations.

Key Responsibilities:

• Lead the planning and execution of medical device product development and commercialization projects from concept through launch.

• Define project scope, objectives, deliverables, and success criteria in collaboration with cross-functional stakeholders.

• Develop and maintain detailed project plans, timelines, resource allocations, and budgets.

• Ensure alignment between project goals and organizational strategy through effective stakeholder management.

• Serve as the primary liaison among R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure seamless project execution.

• Coordinate and track cross-functional deliverables, facilitating effective communication and issue resolution.

• Lead project team meetings, design reviews, and phase-gate reviews, ensuring all actions and decisions are documented.

• Drive accountability across teams to meet milestones and maintain compliance with design control and quality system requirements.

• Ensure all project activities align with Design Control (21 CFR 820.30), ISO 13485, ISO 14971, and other applicable standards.

• Partner with Regulatory and Quality teams to support technical documentation, risk management, and DHF maintenance.

• Manage change control processes and ensure that design and process changes are properly evaluated, documented, and approved.

• Identify potential project risks and mitigation strategies, maintaining proactive issue resolution throughout the project lifecycle.

• Monitor project budgets, costs, and resource utilization, providing regular updates to leadership.

• Ensure timely escalation of risks, delays, or quality concerns that could impact project deliverables.

• Support the development and implementation of best practices, templates, and processes to enhance project management effectiveness.

• Contribute to continuous improvement initiatives related to project governance, documentation, and cross-functional collaboration.

• Leverage project metrics and lessons learned to improve execution efficiency and product quality outcomes.

Must-Have Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Project Management, Business, or a related field.

• Proven experience managing projects in a regulated medical device, biotechnology, or pharmaceutical environment.

• Strong understanding of product development processes, design control, and risk management (ISO 14971).

• Proficiency with project management tools such as MS Project, Smartsheet, or equivalent.

• Demonstrated ability to manage multiple complex projects simultaneously.

• Excellent communication, documentation, and stakeholder management skills.

• Strong problem-solving, analytical, and organizational abilities.

Preferred Qualifications:

• PMP, PRINCE2, or equivalent Project Management certification.

• Experience with new product introduction (NPI), process validation (IQ/OQ/PQ), or post-market engineering projects.

• Familiarity with MDSAP, EU MDR, and other international medical device frameworks.

• Experience in Agile or hybrid project management environments.

• Knowledge of resource planning, cost control, and vendor management in regulated product development.

This is intended for inclusion in Pharmavise’s talent database to build a qualified pool of professionals for future medical device client requisitions.

Details
Originally posted on Himalayas