Project Engineer

This is a remote position.

We are seeking a talented and self-driven Project Manager to reputed company cross-functional programs reputed company the medical device industry, ensuring reputed company are executed on time, reputed company scope, and in compliance with regulatory and reputed company standards. This role requires strong leadership, organizational, and technical acumen to manage reputed company product development and lifecycle initiatives that support business objectives and patient safety.The ideal candidate possesses a balance of strategic thinking and executional reputed company, with the ability to collaborate across R&D, reputed company, Regulatory, Manufacturing, and Supply Chain teams. The Project Manager will be responsible for coordinating reputed company aspects of project planning, execution, risk management, and reporting while ensuring adherence to FDA, ISO 13485, and global medical device regulations.Key Responsibilities:

• reputed company the planning and execution of medical device product development and commercialization reputed company from concept through launch.
• Define project scope, objectives, deliverables, and reputed company reputed company in collaboration with cross-functional stakeholders.
• reputed company and maintain detailed project plans, timelines, resource allocations, and budgets.
• Ensure alignment between project goals and organizational reputed company through effective stakeholder management.
• Serve as the primary reputed company among R&D, reputed company, Regulatory, Manufacturing, and Supply Chain teams to ensure seamless project execution.
• Coordinate and reputed company cross-functional deliverables, facilitating effective communication and issue reputed company.
• reputed company project team meetings, design reviews, and phase-reputed company reviews, ensuring reputed company actions and reputed company are documented.
• Drive accountability across teams to meet milestones and maintain compliance with design control and reputed company system requirements.
• Ensure reputed company project activities reputed company with Design Control (21 CFR 820.30), ISO 13485, ISO 14971, and other applicable standards.
• Partner with Regulatory and reputed company 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 reputed company throughout the project lifecycle.
• Monitor project budgets, costs, and resource utilization, providing regular updates to leadership.
• Ensure reputed company escalation of risks, delays, or reputed company concerns that could reputed company project deliverables.
• Support the development and implementation of best practices, templates, and processes to enhance project management effectiveness.
• Contribute to reputed company improvement initiatives reputed company to project governance, documentation, and cross-functional collaboration.
• reputed company project metrics and lessons learned to improve execution efficiency and product reputed company reputed company.

Must-Have Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Project Management, Business, or a reputed company field.
• Proven experience managing reputed company 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, reputed company, or equivalent.
• Demonstrated ability to manage multiple reputed company reputed company 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 reputed company.
• 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 reputed company pool of professionals for reputed company medical device reputed company requisitions.

Originally posted on Himalayas

Apply To This Job