Program Manager

Program Manager – Interventional Medical Device Manufacturing

Position Overview:

We are seeking a skilled and experienced Program Manager to join our dynamic team in Minnesota. As a Program Manager specializing in interventional medical device manufacturing, you will play a crucial role in leading and overseeing the successful execution of complex projects related to the development, production, and launch of innovative medical devices. Your primary focus will be on ensuring the timely and efficient delivery of high-quality medical devices that comply with regulatory standards while adhering to company goals and objectives.

Responsibilities:

1. Project Planning and Execution: Develop comprehensive project plans, timelines, and budgets for interventional medical device manufacturing projects. Lead cross-functional teams to execute projects efficiently, ensuring alignment with established goals and objectives.
2. Resource Management: Effectively allocate resources, including personnel, equipment, and materials, to meet project milestones and deadlines while managing budget constraints.
3. Regulatory Compliance: Stay abreast of regulatory requirements and ensure that all interventional medical device manufacturing projects adhere to relevant industry standards and regulations, including FDA guidelines and ISO compliance.
4. Risk Management: Identify potential risks and challenges associated with the manufacturing process and implement proactive mitigation strategies to minimize disruptions and delays.
5. Stakeholder Communication: Establish strong communication channels with internal and external stakeholders, providing regular project updates, addressing concerns, and fostering collaborative relationships.
6. Quality Control and Assurance: Ensure adherence to strict quality control procedures throughout the manufacturing process, maintaining the highest standards of product quality and reliability.
7. Continuous Improvement: Champion a culture of continuous improvement, implementing best practices and innovative approaches to enhance operational efficiency and overall product quality.
8. Cost Management: Monitor project expenses, identify cost-saving opportunities, and make data-driven decisions to optimize project budgets.
9. New Product Introduction (NPI): Manage the seamless integration of new products into the manufacturing process, coordinating with R&D, Engineering, and other departments to ensure a smooth transition.
10. Performance Metrics: Define key performance indicators (KPIs) and regularly measure and report on project progress, addressing any variances and taking corrective actions as needed.

Qualifications:

• Bachelor’s or Master’s degree in Engineering or a related field.
• Proven experience (minimum 4 years) in Program Management with a focus on interventional medical device manufacturing.
• Strong understanding of medical device regulations and quality standards (FDA, ISO, etc.).
• Demonstrated success in leading cross-functional teams and managing complex projects from inception to completion.
• Excellent communication, leadership, and problem-solving skills.
• Experience with risk management and mitigation strategies in a regulated environment.
• Familiarity with Lean or Six Sigma methodologies is a plus.
• PMP certification or equivalent project management credentials are advantageous.

Company Benefits:

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits package.
• Professional development and training opportunities.
• Exciting and collaborative work environment with a focus on innovation.
• Opportunity to make a significant impact on the medical device industry and improve patient outcomes.

Please reach out if you feel this could be the next role for you and we can arrange time to discuss further!

Email: rowan.porter@medical-cm.com

Phone: +1 929-294-7260