Aptyx
The Manufacturing PM plays a critical role in leading medical injection molding and assembly programs from concept through to commercial launch. This role combines strategic oversight with hands-on leadership, ensuring that all manufacturing programs are delivered on time, within scope and budget, and in full compliance with regulatory, quality, and customer expectations.
The ideal candidate brings deep experience in regulated manufacturing environments, excels at cross-functional leadership, and is passionate about continuous improvement, technical excellence, and delivering innovative solutions to customers in the medical device space.
In addition to new program development, this role will also support the transition and ongoing oversight of current programs, including relocation of manufacturing programs between sites. This includes planning and executing knowledge transfer, tooling moves, and validation activities to ensure business continuity and customer satisfaction.
Key Responsibilities
Management & Execution
Manage the full lifecycle of manufacturing programs-from initial scoping and planning to execution, validation, and launch.
Oversee site-to-site project transfers, ensuring smooth relocation of tooling, equipment, processes, and documentation with minimal disruption to production or quality.
Develop and maintain comprehensive program plans, including schedules, resource allocation, risk management, and budgets.
Ensure alignment between program objectives, customer requirements, and strategic business goals.
Use Smartsheet or similar tools for real-time scheduling, task tracking, and program transparency.
Provide structured oversight and improvement planning for existing and legacy programs.
Cross-Functional Leadership
Lead cross-disciplinary teams including Engineering, Production, Quality, Tooling, and Supply Chain.
Facilitate communication and coordination across departments, vendors, and customers to ensure unified progress.
Drive accountability through regular team meetings, status updates, and collaborative problem-solving sessions.
Customer Engagement & Relationship Management
Serve as the primary point of contact for customer communications throughout the program lifecycle.
Establish and maintain strong client relationships, ensuring satisfaction through responsiveness, transparency, and results.
Provide consistent updates on program milestones, challenges, and solutions, ensuring full alignment with customer expectations.
Process Improvement & Operational Excellence
Champion continuous improvement initiatives to optimize manufacturing efficiency, reduce waste, and improve process capability.
Analyze KPIs and program performance metrics to identify trends, issues, and improvement opportunities.
Promote Lean, Six Sigma, and other data-driven methodologies to deliver measurable operational gains.
Regulatory, Quality & Compliance Oversight
Ensure all programs adhere to relevant medical device regulations and standards, including FDA (21 CFR Part 820), ISO 13485, and customer-specific quality requirements.
Partner with Quality and Regulatory teams to integrate validation, risk analysis (e.g., DFMEA/PFMEA), and document control into program execution.
Oversee and support quality assurance activities, ensuring timely resolution of non-conformances and audit readiness.
Technical & Industry Expertise
Leverage knowledge of injection molding, plastics processing, and medical assembly methods to inform decisions and guide technical discussions.
Use ERP systems (IQMS, Epicor, SAGE 100, or equivalent) to manage materials, resources, production schedules, and cost tracking.
Ensure designs for manufacturability and scalability, working closely with engineering teams to meet program and production readiness goals.
The ideal candidate brings deep experience in regulated manufacturing environments, excels at cross-functional leadership, and is passionate about continuous improvement, technical excellence, and delivering innovative solutions to customers in the medical device space.
In addition to new program development, this role will also support the transition and ongoing oversight of current programs, including relocation of manufacturing programs between sites. This includes planning and executing knowledge transfer, tooling moves, and validation activities to ensure business continuity and customer satisfaction.
Key Responsibilities
Management & Execution
Manage the full lifecycle of manufacturing programs-from initial scoping and planning to execution, validation, and launch.
Oversee site-to-site project transfers, ensuring smooth relocation of tooling, equipment, processes, and documentation with minimal disruption to production or quality.
Develop and maintain comprehensive program plans, including schedules, resource allocation, risk management, and budgets.
Ensure alignment between program objectives, customer requirements, and strategic business goals.
Use Smartsheet or similar tools for real-time scheduling, task tracking, and program transparency.
Provide structured oversight and improvement planning for existing and legacy programs.
Cross-Functional Leadership
Lead cross-disciplinary teams including Engineering, Production, Quality, Tooling, and Supply Chain.
Facilitate communication and coordination across departments, vendors, and customers to ensure unified progress.
Drive accountability through regular team meetings, status updates, and collaborative problem-solving sessions.
Customer Engagement & Relationship Management
Serve as the primary point of contact for customer communications throughout the program lifecycle.
Establish and maintain strong client relationships, ensuring satisfaction through responsiveness, transparency, and results.
Provide consistent updates on program milestones, challenges, and solutions, ensuring full alignment with customer expectations.
Process Improvement & Operational Excellence
Champion continuous improvement initiatives to optimize manufacturing efficiency, reduce waste, and improve process capability.
Analyze KPIs and program performance metrics to identify trends, issues, and improvement opportunities.
Promote Lean, Six Sigma, and other data-driven methodologies to deliver measurable operational gains.
Regulatory, Quality & Compliance Oversight
Ensure all programs adhere to relevant medical device regulations and standards, including FDA (21 CFR Part 820), ISO 13485, and customer-specific quality requirements.
Partner with Quality and Regulatory teams to integrate validation, risk analysis (e.g., DFMEA/PFMEA), and document control into program execution.
Oversee and support quality assurance activities, ensuring timely resolution of non-conformances and audit readiness.
Technical & Industry Expertise
Leverage knowledge of injection molding, plastics processing, and medical assembly methods to inform decisions and guide technical discussions.
Use ERP systems (IQMS, Epicor, SAGE 100, or equivalent) to manage materials, resources, production schedules, and cost tracking.
Ensure designs for manufacturability and scalability, working closely with engineering teams to meet program and production readiness goals.