Atrium Medical Corporation is looking to increase its products' quality through systematic redesign following the analysis of incoming issues. The Technical Product Manager will be responsible for monitoring and evaluating the overall product safety, performance, and compliance for assigned product areas and ensuring necessary countermeasures and improvements are initiated.
Requirements
- Advanced knowledge/experience of medical device regulations
- Demonstrated experience working in Quality Management Systems
- Proficient knowledge/experience in product development and manufacturing production of medical devices
- Working knowledge/experience in problem solving tools e.g. lean, fishbone diagram, value stream mapping etc.
- Strong computer skills, including MS Office applications (Word/Excel) are required.
- Must have the ability to lead and indirectly manage senior personal across all business functions
- Highly organized with strong project management and technical abilities.
Responsibilities
- The TPM is responsible for the establishment and oversight of the Product Care Group (PCG).
- The TPM is responsible for the creation and standardization of the business processes required to integrate the PCG into our normal business practices in Merrimack.
- The TPM must ensure the PCG works as a cross functional team with the responsibility to monitor and evaluate the overall product safety, performance, and compliance, as well as to initiate countermeasures and act upon trends or severities in other processes.
- The TPM must, by leading the PCG, manage and mitigate acute/serious product concerns.
- They will identify and drive the investigation of urgent product issues that arise and ensure solutions to “design defects” and/or “device non-conformances” are implemented with urgency.
- The TPM will be expected to have a hands on, highly proactive perspective.
- They will lead the PCG to monitor different product quality related trends and suggest necessary countermeasures to proactively improve product quality through establishing different quality roadmaps (e.g. initiatives taken and future initiatives).
Other
- Minimum five years of demonstrated leadership experience in Research and Development, Manufacturing Engineering, and/or Project Management within a medical device quality management system.
- Ability to work with flexible and changing production and project schedules.
- Self-motivated and have the ability to problem solve on a regular basis.
- Strong negotiation and collaboration skills required.
- Individual must be able to lead and influence other senior personnel in the organization to ensure issues are identified and countermeasures executed in a timely manner
