Job Description




Job Summary


The Product Configuration Manager will play a critical role in re-defining the product definition and configuration system. A key deliverable is to provide a refreshed vision for the configuration team. This position is responsible for ensuring that all product configurations are correctly documented, maintained, accurately costed and compliant with applicable regulations and standards. Prior experience in a regulated industry such as medical devices is highly preferred. The successful candidate will collaborate closely with engineering, regulatory, quality, cost accounting and manufacturing teams to ensure that product configurations meet customer needs and regulatory requirements.


Job Responsibilities


Develop, implement, and manage configuration management processes to maintain the integrity and traceability of product configurations.

Oversee the creation and maintenance of product configuration documentation, including bills of materials (BOMs), engineering change orders (ECOs), and product data management (PDM) systems.

Ensure that all product configurations are documented accurately and reflect the current product status.

Provide configuration and costing subject matter expert leadership at all times.

Ensure product configurations comply with regulatory requirements, ISO 9001, ISO 13485 and other applicable standards. Working knowledge of FDA requirements is a plus.

Participate in internal and external audits related to product configuration and provide necessary documentation and support.

Work closely with cross-functional teams, including R&D, quality, manufacturing, and regulatory affairs, to ensure seamless product configuration management.

Act as the primary point of contact for configuration-related inquiries and issues.

Continuously evaluate and improve configuration management processes to enhance efficiency, accuracy, and compliance.

Implement best practices and tools for configuration management, and provide training to relevant stakeholders.

Manage and control changes to product configurations, ensuring that all changes are evaluated, approved, and documented properly.

Coordinate with relevant teams to ensure that changes are implemented effectively and that any impacts on product quality or regulatory compliance are addressed.


Qualifications

• Required: Bachelor's degree in Engineering, Biomedical Engineering, or a related field. A Master's degree is a plus.
• Preferred: Minimum of 5 years of experience in configuration management, preferably within the medical devices industry.
• Knowledge:

• Strong understanding of configuration management principles and practices.
• Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485).
• Experience with PDM/PLM software (e.g., Windchill, Agile, SAP).