Technical Product Manager

Job Overview

The main purpose of the Technical Product Manager (TPM) role is to increase our products quality through systematic redesign following the analysis of incoming issues. Responsibilities will include monitoring and evaluating the overall product safety, performance and compliance for assigned product area/s and to make sure necessary countermeasures and improvements are initiated in the organization. The TPM will ensure there are actions ongoing for important product safety, performance and short-term non-compliance issues in products delivered and/or to prevent those issues from being distributed in products to the field.

Job Responsibilities and Essential Duties

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 purpose of the PCG is to have a structured team and process to monitor and evaluate overall product quality and to initiate countermeasures and improvements when appropriate.   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 has the authority to adjust the composition of the team members on the PCG as needed to ensure team dynamics support a highly effective team.  

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).

The TPM ensures that implementation of countermeasures are coordinated with Project Management and ongoing product development projects or design change projects when possible.

The TPM is expected to monitor the following business areas and perform as follows:

Distributed Product:

• Participate in and review complaint investigations on product already distributed to the customer.

• Participate in complaint trend meetings according to complaint handling process.

• Review complaint trending data and initiate necessary counter measures via the PCB.

• Be aware of and give input to complaint risk assessments.

▪ Participate in Health Hazard Evaluations (HHE) ensuring they are completed in a timely manner.

▪ Use the conclusions of the HHE to initiate necessary counter measures via the PCB.   

Sourcing and Supply (SAS):

• Support  different investigations, e.g. production non-conformities related to Non-Conformance Reports (NCR) and when needed identify and initiate countermeasures if the problem affects safety, performance and compliance.

▪ Regarding deviations, the TPM is made aware from production and is responsible for identifying and directing the correct cross functional resources to help determine the risk (if needed) and to stop the production.

Support Processes:

• When a Field Action is triggered: Direct the cross functional activities. Progress of a field action is monitored in PCB.

• Monitor the Post Market Surveillance Report (PSUR), its status, and any issues arising from the PMS data.   

Management Processes:

• When a Quality Hold is triggered: Direct the cross-functional activities and monitor progress of a quality hold in PCG.

• Act as  SME (Subject Matter Expert) during audits when it comes to PCG.

Minimum Requirements

• Bachelor of Science in Engineering or equivalent
• Minimum five years of demonstrated leadership experience in Research and Development, Manufacturing Engineering, and/or Project Management within a medical device quality management system.

Required Knowledge, Skills and Abilities

• Must have the ability to lead and indirectly manage senior personal across all business functions
• 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.
• Ability to work with flexible and changing production and project schedules.
• Self-motivated and have the ability to problem solve on a regular basis.
• Highly organized with strong project management and technical abilities.
• Strong negotiation and collaboration skills required.
• Strong computer skills, including MS Office applications (Word/Excel) are required.

Supervision/Management Of Others:

• Position has no direct reports and is not responsible for the development and management of personnel

Internal and External Contacts/Relationships

• The role involves close collaboration with colleagues in manufacturing, purchasing, product development, complaints, quality and regulatory, product management, clinical and medical affairs etc.
• 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
• Contacts with service and sales units (SSU) and suppliers could also occur.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• Physical requirements are minimal for this position.  Office/cubicle setting with minimal physical exertion required.
• Minimal travel may be required for this position.  0-2 trips/year may necessary.

Annual salary of $115K to 130K depending on relevant experience and 15% STIP

#LI-YA2 #LI-Hybrid