Position Summary:

An ideal Project Manager will have a strong background in project management methodologies, excellent communication skills, and a deep understanding of project completion processes and regulations. As a Project Manager, you will be responsible for overseeing the planning, implementation, and execution of various projects within our organization, ensuring they are completed on time, within budget, and meet quality standards.

Essential Duties and Responsibilities:

Project Coordination & Execution:

• Spearhead cross-functional project meetings, following a structured process from initiation to closure.
• Implement project management best practices to define strategies, planning, scheduling, and coordination.
• Guide the project lifecycle, ensuring stage-gate processes are adhered to for effective delivery.

Stakeholder & Team Engagement:

• Serve as the primary point of contact for both internal teams and external collaborators.
• Drive stakeholder engagement, ensuring alignment on project scope and managing scope changes.
• Facilitate communication across project teams to maintain focus on goals and timely task completion.

Performance & Quality Management:

• Oversee project performance, setting and tracking objectives, priorities, and standards.
• Assure quality by adhering to medical device standards and regulatory requirements.
• Implement risk management strategies, including failure mode analysis, to ensure high-quality deliverables.

Scheduling & Tracking:

• Manage project timelines, monitor critical path activities, and proactively address delays.
• Report progress against milestones and manage the critical timing of project activities.

Communication & Documentation:

• Lead project communications, keeping all stakeholders informed about progress and decisions.
• Maintain comprehensive documentation, including progress reports and risk assessments.

Resource Allocation:

• Ensure optimal resource utilization, balancing personnel, budget, and equipment needs.
• Build and leverage relationships to influence and direct project teams effectively.

Change Management:

• Navigate project changes smoothly, applying change management techniques to maintain project integrity.

Competencies:

To perform this job successfully, an individual should demonstrate the following competencies:

Drive for Results- Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results

Project Management - Executes project start-up and planning activities. Defines & manages schedules, & resources to accomplish project objectives and reports on project progress. Identifies and manages scope, risks and quality throughout the project lifecycle. Identifies and partners with stakeholders to develop and implement change management plans.

Communication -Expert communication skills in one-on-one situations and to a large group. Probes for information in a way that is easy to understand.

Relationship Builder - Deeply embedded within the organization, creating, strengthening and protecting the relationship between departments. Generate meetings with colleagues and facilitating collaborative efforts towards project completion

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individual’s disabilities to perform the essential functions.

Education and/or Experience:

Academic background in Life Sciences, Engineering, Pharmaceutical, or related fields is preferred.

PMP certification preferred

Extensive experience in project management within the medical device sector.

Proficient in quality management systems, with a deep understanding of change control and design control processes.

Comprehensive knowledge of medical device regulations (e.g., ISO 14971, ISO 13485, 21 CFR 820, EU Regulation 2017/745) preferred

Excellent verbal and written skills

Excellent Organizational Skills

Proficiency with Microsoft Office Suite

Physical Demands:

Individuals may need to sit or stand as needed, may require walking primarily on a level surface for periodic periods during the day, reaching above shoulder heights, below waist or lifting as required to file documents or store materials throughout the day. Travel up to 10% may be required.