Project Manager(Medical Devices)

Proven leadership track record of large, complex medical systems that include capital and disposable product development.

ISO 13485;FDA 21CFR 820;IEC 60601; Risk Management ? ISO 14791; Requirements Management; Verification & Validation; Design Transfer; Managing DHF; MDD / MDR

Proficiency in MS Office applications

Good problem solving skills and interpersonal skills that including working in a team environment and ability to indirectly lead others.

Foster a diverse workplace that enables all participants to contribute to their full potential.

Excellent organizational skills, interpersonal skills, and strong verbal, written, and presentation skills.

Strong Emotional Intelligence, situational leadership, and ability to manage by influence

Results-oriented, positive attitude focused on delivering timely, accurate and best in class execution

Comfortable communicating to and presenting in front of all levels of the organization

Proficiency inSmart Sheets

·10 + Years [ but can be adjusted for right candidates]

·Indirectly manages large cross-functional development teams; leads teams effectively; provides input to functional managers on team and team member performance.

·identifies, communicates, and manages moderate to high levels of risk.

·Manages key initiating, planning, executing, controlling, and closing processes; develops and implements project plan; builds team ownership and commitment to project plan; mentors and/or coaches other functional and project managers.

·Initiates projects and programs; leads team to complete activities to current policies and practices; keeps documentation organized, creates working plan and helps maintain Design History File for the project. Identifies process improvements affecting multiple projects.

·Responsible for team and cross-functional communications; liaison between the team and the senior leadership; leads phase and business reviews, project meeting minutes, issues log, metrics, and other key communications. Communicates and influences resolution of cross-functional issues.

·Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

·Establishes operating policies & procedures that affect immediate subordinate organizational units and may have company-wide effect. Interprets, executes, and recommends modifications to organizational policies.

·Functions as an advisor to subordinates supervisors or staff members to meet schedules or resolve technical or operational problems. Develops and administers mid- to long range plans, budgets, schedules, and performance standards.

·Develops and communicates a vision for the program/organizational unit assigned. Builds consensus for operating goals that are in alignment with the company. Provides leadership to assigned staff and supervisors by communicating and providing guidance towards achieving department objectives.

·Assignments are expressed in the form of objectives; makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Exerts influence in the development of overall strategy, objectives and long-range goals.

·Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

Purpose

·The Project Manager is a self-motivated leader of projects & programs. The incumbent is responsible for managing timelines and budgets through a cross-functional team to ensure successful completion of assigned projects