Director, Project Management

Healthmark, A Getinge company was founded in 1969 and employs over 300 people and is a growing company. We strive to provide customers with quality products and support services in a timely and effective manner. 

This will be a defined term position for 8 months. Schedule will be three days per week, 60% FTE. Extra Days when pre-agreed.  The role requires travel. Travel anticipated to average 20% annually but may vary depending on project needs.

Job Purpose:

The Director, Project Management will lead and represent the Project Management Office (PMO) department for the Surgical Workflows-Infection Control (IC) U.S. Market , overseeing the technical management of project teams to drive the successful execution of key projects. This individual will focus on ensuring that R&D projects within the organization are delivered on time, within budget, and meet all quality and compliance standards, particularly with regard to FDA submissions. The role involves collaborating with various stakeholders across R&D sites, managing resources and budgets, and continuously optimizing project processes and methodologies. The Director will also focus on maintaining operational and legal compliance while supporting cross-functional teams to meet project goals and milestones.  

Key duties and responsibilities:

 ·  Lead and represent the Project Management Office (PMO) department, overseeing the technical management of project teams on a project-by-project basis.

·  Optimize the organization and performance of projects in close coordination with the R&D Directors for Integrated Circuits (IC).

·  Specifically manage and support the FDA submission status of key projects

·  Implement and monitor operational and legal requirements related to medical device development.

·  Plan and allocate resources, and manage project budgets in coordination with R&D stakeholders and Product Managers.

·  Ensure the quality-compliant development of medical devices in alignment with quality systems, manuals, and regulatory guidelines.

·  Define, implement, and optimize development processes, methods, and organizational structures to enhance efficiency, quality, and output.

Monitor project progress, focusing on work results, including efficiency and quality, and ensure alignment with project objectives.

·  Develop and enhance project management processes, best practices, and competencies for managing R&D projects.

·  Collaborate with project teams on key performance indicators (KPIs), methodologies, and tracking to ensure successful implementation of projects.

·  Act as a neutral authority, monitoring project progress and supporting the collaboration between the IC R&D Director and Heads of R&D across different sites (Detroit, Denver, Tampa).

·  Address project risks and issues proactively, ensuring mitigation strategies are in place and are communicated effectively.

Knowledge/Skills/Experience:

•  Knowledge of Medical Device Development: In-depth understanding of medical device development processes, including compliance with FDA regulations and international standards.
• Project Management Expertise: Strong experience in managing complex projects, including resource and budget planning, timeline management, and risk mitigation.
• Regulatory Knowledge: Deep knowledge of FDA submission processes, including 510K and De Novo submissions, and familiarity with industry standards for medical devices.
• Leadership Skills: Proven ability to lead cross-functional teams, providing direction and support while ensuring collaboration among various stakeholders.
• Process Optimization: Experience in defining and optimizing development processes and methodologies to improve project outcomes.
• Communication Skills: Exceptional communication skills to interact effectively with senior leadership, project teams, and external stakeholders.
• Problem-Solving: Strong analytical and problem-solving skills to address issues related to project progress, timelines, and compliance.
• Quality Management: Thorough understanding of quality management systems (QMS) and the ability to implement and monitor quality standards.
• Financial Acumen: Ability to plan, manage, and track budgets for multiple projects effectively.

  Education Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Business Administration, or a related field.
• A Master’s degree in Business Administration (MBA), Project Management, or Engineering is highly desirable

  Years of Industry Experience:

• A minimum of 10-15 years of experience in project management, with at least 5-7 years in a leadership role overseeing R&D projects in the medical device or healthcare industry.
• Proven experience with FDA submissions (510K, De Novo) and capital equipment launches is highly preferred.
• Strong background in leading cross-functional teams across multiple sites is a plus.

• Personal qualities:

  ·  Results-Oriented: Driven to achieve project milestones and organizational goals with a focus on efficiency, cost-effectiveness, and quality.

  ·  Strategic Thinker: Able to see the big picture and plan long-term, while still managing the daily aspects of project execution.

  ·  Collaborative: Strong team player who works well with diverse teams across various locations, building consensus and fostering positive working relationships.

  ·  Detail-Oriented: Demonstrates a meticulous attention to detail, ensuring all aspects of the project are aligned with regulations and quality standards.

  ·  Adaptable: Flexible and able to thrive in a fast-paced and dynamic environment, handling multiple projects and priorities effectively.

  ·  Proactive: Takes initiative in identifying potential risks and implementing solutions before problems escalate.

  ·  Decisive: Comfortable making critical decisions, often under pressure, to keep projects on track and aligned with business goals.

The base salary for the fixed term position is a minimum of $180,000 and a maximum of $220,000