POSITION SUMMARY.

The Change Control Manager will be responsible for managing engineering change process for the DASH system. Embedded in the engineering team, they will interface with the quality organization to ensure that changes related to design adhere to the company’s change control process as well as all regulatory requirements (ISO, CFR). The individual will collaborate closely with Engineering team members for the generation and completion of change orders, in addition to change coordination with cross-functional teams including, Quality/Regulatory, Customer Support, and Operations, to on product changes.

EDUCATION, QUALIFICATIONS, AND/OR EXPERIENCE.

• Bachelor’s degree in engineering, Life science or a related field.
• At least 5 years of proven experience in support of complex electrical, mechanical, and assay development and/or manufacturing operations in the medical device or diagnostic industry.
• Experience with regulatory compliance and standards in the medical device industry (ISO 13485, FDA regulations); ability to operate in an FDA-regulated environment.
• Demonstrated experience in change process documentation and completion supporting on-market products as well as products in development
• Excellent problem-solving skills and the ability to troubleshoot and debug complex systems.
• Effective communication and collaboration skills, with the ability to work in interdisciplinary teams.
• Strong attention to detail and commitment to producing high-quality, reliable products and documentation.

Physical Requirements.

• Repetitive Motion: Mostly computer use
• Weight Lifting: < 25 lbs
• Position: Mostly sitting
• Speaking and communicating
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

• Oversee implementation of engineering design changes compliant with Nuclein’s change control processes
• Collaborate with cross-functional teams to prioritize and implement change requests
• Supports technical staff at Change Control Board meetings
• Translates change orders and their impact to Design Control documentation, Ensures Design Control documentation is updated as required.
• Coordinates change control implementation with Operations as required
• Develops and suggests methods for change order verification and validation as required
• Train engineering team members on the change control process with the goal of improving the knowledge and quality level of submitted change control records.
• Gain expertise and appropriate ownership of engineering documentation in collaboration with the quality organization.
• Collaborate closely with cross-functional teams to address obsolescence issues and implement solutions that ensure the long-term availability and reliability of components.
• Drive continuous improvement in change processes, documentation, quality and efficiency
• Stay current with industry trends, emerging technologies, and regulatory standards relevant to medical device change support