Senior Engineering Manager, MedTech NPI & Validation

AJR Enterprises, LLC; Chicopee (MA); On-site; USD 140,000 - 155,000; Full time

Benefits offered by this job

Healthcare benefits

401K with match

Paid time off & holidays

Job summary

UFP Technologies, Inc. in Chicopee, MA is seeking a Senior Engineering Manager to lead customer-facing engineering programs, including new product introductions, process development, and program validation for medical technology customers.

The role manages complex programs from planning through validation and manufacturing transition, ensuring requirements, timelines, budgets, quality standards, and business objectives are met. Mentors engineers and drives cross-functional alignment.

Qualifications

• Bachelor of Science degree in Engineering or 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 standards.
• Expertise in project management, PLM, NPI, and validation.
• Proven ability to lead complex, customer-facing engineering programs with scope, schedules, budgets, risks, and customer expectations.
• Strong customer relationship management, communication, and collaboration skills across functions.
• Ability to mentor engineering teams and drive continuous improvement.

Responsibilities

• Manages team of 3–6 Engineers and develops engineering personnel.
• Oversees NPI from Advanced Engineering through process development, validation, and transition to manufacturing.
• Directs validation activities for new and existing medical technology programs; maintains validated state.
• Serves as primary engineering contact for customers, communicates status, manages expectations, and resolves issues.
• Leads cross-functional collaboration with Quality, Manufacturing, Program Management, and others to align priorities and deliverables.
• Oversees engineering changes to maintain quality and regulatory compliance.

Skills

Leadership

Project management

Cross-functional collaboration

Problem solving

Customer relationships

Education

Bachelor of Science in Engineering

Master's degree preferred

Tools

PLM

Job description

UFP Technologies, Inc. in Chicopee, MA is seeking a Senior Engineering Manager to lead customer-facing engineering programs, including new product introductions, process development, and program validation for medical technology customers.

The role manages complex programs from planning through validation and manufacturing transition, ensuring requirements, timelines, budgets, quality standards, and business objectives are met. Mentors engineers and drives cross-functional alignment.