Manufacturing Lead

Warwick Consulting Limited; Massachusetts; On-site; USD 120,000 - 180,000; Full time

Job summary

Warwick Consulting Limited in Massachusetts seeks a Manufacturing Lead to coordinate readiness, production planning, supplier performance, and lifecycle support for regulated medical devices.

You will blend manufacturing execution with project management to deliver design transfer, V&V, ramp-up, and sustaining activities. You will partner with Product Management, Demand Planning, SCM, and external manufacturers.

Qualifications

• Bachelor's degree in a related engineering or management discipline.
• 6-8+ years in manufacturing engineering, operations, NPI, or production readiness.
• Experience coordinating cross-functional teams and external partners.
• Familiarity with ISO 13485, FDA requirements, and design controls.
• Strong communication and escalation skills with stakeholder management.

Responsibilities

• Manufacturing planning and execution, including schedules, capacity, and materials.
• Lead cross-functional projects, manage risks, and track milestones.
• Partner with Product Management and Demand Planning on roadmaps and launches.
• Coordinate external manufacturers, OEMs, and suppliers for delivery commitments.
• Address supplier quality issues and drive CAPA and continuous improvement.
• Oversee design transfer, qualification builds, and production readiness.
• Identify supply risks, material shortages, and mitigation plans.
• Support lifecycle management, changes, and regulatory compliance.

Skills

Project management

Cross-functional

Manufacturing planning

Demand planning

Supplier coordination

Quality systems

Regulatory compliance

Product lifecycle management

Stakeholder management

PMP certification

Education

Bachelor's degree

Job description

Warwick Consulting is a comprehensive medical device and life sciences consulting firm that simplifies complexity across the full product lifecycle, from concept and design through regulatory approval, commercialization, and post-market support. We partner with organizations ranging from early-stage innovators to global industry leaders, delivering tailored, results-driven solutions across engineering, quality systems, regulatory affairs, cybersecurity, risk management, human factors engineering, product quality, and FDA remediation. By integrating deep industry expertise with innovative, AI-enabled solutions, including our VERA QMS Assurance platform, we help clients address complex challenges, strengthen compliance, improve operational efficiency, and accelerate innovation. Our experienced consultants provide flexible on-site, hybrid, and remote support, delivering the right expertise when and where it is needed most.

Position Overview:

The Manufacturing Lead is responsible for coordinating and driving manufacturing readiness, production planning, supplier performance, manufacturing transfer, and lifecycle support for products used in regulated medical device applications.

This role combines manufacturing execution with project management to ensure successful delivery of product development, design transfer, verification and validation (V&V) support, production ramp-up, and sustaining activities. The Manufacturing Lead works across functional teams and external partners to deliver manufacturing commitments on schedule, within cost targets, and in compliance with applicable quality standards and regulatory requirements.

The role serves as a key interface between Product Management, Demand Planning, Supply Chain Management (SCM), Purchasing, Hardware and Software Engineering, Systems Engineering, Quality, Regulatory, Operations, Service, suppliers, original equipment manufacturers (OEMs), and external manufacturing partners. The position is responsible for aligning product demand with manufacturing capacity, material availability, supplier commitments, and production readiness.

The Manufacturing Lead drives cross-functional execution by establishing integrated plans, managing dependencies, monitoring milestones, identifying and mitigating risks, resolving operational constraints, and escalating issues that could affect product availability, project timelines, quality, or cost. The role requires strong project management, stakeholder engagement, analytical problem-solving, and supplier coordination skills, with an emphasis on achieving results through influence and collaboration rather than direct people management. This position represents the manufacturing function throughout product development, commercialization, production, and lifecycle sustainment.

Key Responsibilities:

1. Manufacturing Planning and Execution

• Coordinate manufacturing readiness, production schedules, capacity, equipment, and material availability.
• Ensure manufacturing commitments align with product demand and delivery timelines.

2. Project Management and Cross-Functional Execution

• Manage project plans, milestones, dependencies, risks, and deliverables.
• Drive cross-functional alignment, issue resolution, and timely execution.

3. Product Management and Demand Planning

• Partner with Product Management to align product roadmaps, launches, and lifecycle changes.
• Coordinate with Demand Planning to align forecasts, inventory, capacity, and supply requirements.

4. External Manufacturer and Supplier Management

• Coordinate external manufacturers, OEMs, and suppliers on production schedules, capacity, and delivery commitments.
• Resolve supplier constraints, material shortages, and manufacturing delays.

5. Supplier Quality and Manufacturing Quality

• Collaborate with Supplier Quality Engineers to address supplier quality issues and manufacturing defects.
• Track corrective actions and drive continuous quality improvement.

6. Design Transfer and Production Readiness

• Coordinate manufacturing transfer, qualification builds, and production readiness activities.
• Support verification and validation, production ramp-up, and manufacturing documentation.

7. Supply Chain Risk and Material Management

• Identify and mitigate component shortages, long lead times, and supplier capacity risks.
• Coordinate sourcing, inventory, and recovery plans to maintain supply continuity.

8. Lifecycle and Regulatory Compliance

• Support product upgrades, engineering changes, supplier transitions, and end-of-life planning.
• Ensure compliance with applicable quality systems, regulatory requirements, and change-control processes.

Required Qualifications:

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, Biomedical Engineering, Systems Engineering, Supply Chain Management, Operations Management, or a related discipline.
• Minimum of 6-8 years of experience in manufacturing engineering, manufacturing operations, new product introduction (NPI), production transfer, supply chain operations, supplier management, or technical program management.
• Demonstrated project management experience coordinating cross-functional manufacturing, product development, supply chain, or production readiness initiatives.
• Experience working with Product Management, Demand Planning, SCM, Purchasing, external manufacturers, suppliers, Supplier Quality Engineers, and Engineering teams.
• Strong understanding of manufacturing readiness, design transfer, production planning, supplier coordination, BOM management, configuration control, and product lifecycle management.
• Demonstrated experience developing and maintaining integrated schedules, milestone plans, action trackers, risk registers, issue logs, project dashboards, and management reports.
• Experience managing supply constraints, component shortages, supplier lead times, demand changes, inventory risks, and manufacturing capacity limitations.
• Experience supporting supplier quality investigations, root-cause analysis, CAPA, NCRs, supplier corrective actions, and continuous improvement activities.
• Familiarity with medical device QMS requirements, design controls, risk management, change management, and applicable regulatory requirements, including ISO 13485 and relevant FDA requirements.
• Excellent communication, stakeholder management, negotiation, and escalation skills.
• Proven ability to influence cross-functional stakeholders, drive action ownership, manage competing priorities, and deliver results in a matrixed organization without direct people management responsibility.
• Project Management Professional (PMP) certification or equivalent project management experience.
• Experience with global contract manufacturers, OEMs, distributors, and component suppliers.
• Experience with demand forecasting, supply planning, inventory optimization, supplier recovery planning, and end-of-life material management.
• Experience coordinating manufacturing deliverables across geographically distributed teams and multiple manufacturing locations.
• Experience in medical devices is must.

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.