Senior Medical Device Engineering Manager

Direct Hire Fulltime position for a Senior Medical Device Engineering Manager in Chicopee, MA

Summary:

Reporting to the General Manager, the Senior Engineering Manager leads customer-facing engineering programs, including new product introductions (NPI), process development, and program validation for medical technology customers. This role is responsible for managing complex engineering programs from initial planning through validation and transition to manufacturing, ensuring customer requirements, project timelines, budgets, quality standards, and business objectives are achieved.

This individual leads, mentors, and develops engineering personnel; coordinates cross-functional resources; and drives continuous improvement to support program success, manufacturing performance, and business growth. The role requires a hands-on, solutions-oriented leader who can navigate complex technical challenges, balance competing priorities, and deliver results in a dynamic, customer-focused environment.

Essential Duties and Responsibilities:

• Manages team of 3-6 Engineers. Coaches, and develops engineering personnel, establishing clear expectations, supporting technical growth, and promoting accountability and continuous improvement.
• Oversees New Product Introductions (NPI) from Advanced Engineering through process development, validation, and transition to the manufacturing floor.
• Directs and oversees validation activities for new and existing medical technology programs, ensuring processes remain in a validated state and changes are appropriately managed and documented.
• Serves as a primary engineering point of contact for customers, communicating program status, managing expectations, addressing technical challenges, and driving resolution of issues affecting scope, timing, quality, or cost.
• Cultivates strong, long-term relationships with key decision-makers within accounts and develops a deep knowledge of the customer organization.
• Provides engineering leadership and technical guidance to resolve complex program, process, design, and manufacturing challenges.
• Leads cross-functional collaboration with Quality, Manufacturing, Program Management, Business Development, and other internal teams to ensure alignment on program priorities, resources, and deliverables.
• Oversees engineering change management, including process, design, revision, and documentation changes, to maintain product quality, regulatory compliance, and validated processes.
• Guides the development and implementation of standard operating procedures (SOPs), work instructions, and other technical documentation to support consistent and compliant manufacturing processes.
• Partners with Manufacturing to improve process capability, equipment uptime, product quality, and production efficiency while reducing process variation and operational risk.
• Evaluates bills of materials (BOMs), process costs, and technical risks to identify opportunities for cost reduction, process optimization, and improved program profitability.
• Identifies and develops proposals for design improvements, process enhancements, new technologies, and other customer-focused solutions that support business objectives.
• Leads or supports root cause investigations and corrective actions related to engineering, manufacturing, and quality issues.
• Oversees engineering resource planning and prioritization to ensure adequate technical support for customer programs, validation activities, and manufacturing needs.
• Collaborates with senior leadership and cross-functional stakeholders to establish program priorities, evaluate risks, and align engineering activities with customer commitments and business goals.
• Identifies opportunities to improve engineering processes, project execution, documentation, and communication to strengthen program performance and customer satisfaction.
• Promotes a culture of safety, quality, accountability, innovation, and continuous improvement.

Qualification Requirements:

• Bachelor of Science degree in Engineering or a related technical discipline required; master's degree preferred.
• 7–10 years of progressively responsible engineering experience, including engineering management and team leadership.
• Experience with regulated quality systems, including ISO 9001, ISO 13485, FDA regulations, or equivalent industry standards.
• Expertise in project management, product lifecycle management (PLM), new product introduction (NPI), and validation.
• Proven ability to lead complex, customer-facing engineering programs, managing scope, schedules, budgets, technical deliverables, risks, and customer expectations.
• Strong customer relationship management, communication, and cross-functional collaboration skills, including the ability to engage effectively with customers and senior-level stakeholders.
• Strong technical and analytical skills, with the ability to troubleshoot complex issues, evaluate manufacturing processes, and drive improvements in quality, efficiency, and cost.
• Demonstrated ability to lead, mentor, and develop engineering teams while balancing customer needs with quality, operational, and financial objectives.
• Excellent organizational, resource-planning, and decision-making skills, with the ability to prioritize competing demands and lead through change.
• Detail-oriented, inherently curious, and intrinsically motivated, with a hands-on approach, strong initiative, and a self-starter mentality.
• Excellent written and verbal communication skills, sound judgment, and a commitment to accountability and high standards of performance.