Our client, a premier contract manufacturer specializing in custom medical device manufacturing services, has an immediate opening for a Technical Program Manager. This role will take ownership of all technical and programmatic aspects, ensuring smooth cross-functional collaboration, adherence to timelines and budgets, and the delivery of high-quality products that meet regulatory standards.

Responsibilities:

• Act as the primary liaison between internal teams (engineering, operations, quality, regulatory) and external stakeholders (customers, suppliers) to ensure program alignment, clear communication, and effective issue resolution
• Provide technical guidance on design, manufacturing, and regulatory aspects to ensure products are both technically feasible and compliant with relevant industry regulations (FDA, ISO 13485, etc.)
• Proactively identify program risks, issues, and bottlenecks, and develop risk mitigation strategies. Ensure risk assessments and necessary corrective actions are taken throughout the program lifecycle
• Ensure all aspects of the program meet FDA, ISO 13485, and other applicable regulatory requirements. Lead compliance documentation efforts and coordinate audits as necessary
• Foster strong customer relationships by proactively managing expectations, providing regular updates on program status, addressing concerns, and ensuring successful product delivery
• Drive initiatives to optimize program management processes, reduce costs, improve quality, and enhance efficiency. Identify areas for improvement and implement best practices across the organization
• Maintain comprehensive project documentation, including requirements, design reviews, testing protocols, risk management plans, validation plans, and final deliverables to ensure traceability and compliance
• Guide and mentor cross-functional teams, ensuring that all stakeholders are aligned and motivated to achieve program goals and milestones

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• A minimum of 3 years of experience in program management within the medical device, biotechnology, or other highly regulated industries
• Strong expertise in medical device design and manufacturing processes, including injection molding, CNC machining, laser machining, cannula grinding, and stainless-steel finishing
• Understanding of medical device regulatory frameworks (FDA, ISO 13485) and quality management systems (QMS), with hands-on experience in applying design controls, risk management, and product validation
• Proven success in managing complex, cross-functional teams, with experience in leading projects through the entire process validation phase and into production
• Exceptional communication and interpersonal skills, with the ability to lead diverse teams, manage customer relationships, and align stakeholders across departments
• Proficiency with project management software (MS Project, JIRA, or similar tools) for scheduling, tracking, and reporting project milestones
• PMP, Six Sigma, or similar certifications are a plus