Medical Device Engineering Services Manager

Direct Hire Fulltime position for a Medical Device Engineering Services Manager in Chicopee, MA This role is responsible for leading engineering services, design applications, and technical project execution in support of customer and business objectives. The role spans product design, tooling and fixture development, equipment design and build, validation, new product introductions, and process improvement initiatives. The position serves as a key technical interface between customers, engineering, operations, maintenance, and external vendors to develop innovative manufacturing solutions, support concept development, resolve production challenges, and ensure successful project execution.

Serves as the senior technical resource for the site, providing engineering guidance and direction to engineers, technicians, CAD, and maintenance personnel. Provides design direction for tooling and equipment drawings. Identifies and selects additional vendors necessary to complete projects. Provides design input for company facility layouts, machine layouts, and floor plans. Acts as a working liaison with project engineers, R&D personnel, set-up technicians, and customers to discuss product details and requirements related to tooling and equipment design. Communicates directly with external customers to review tooling designs, collaborating with engineering or upper management. Manages ongoing projects, creating and communicating timelines and deliverables externally and leading progress internally. Leads new product introductions, product transfers, and product launches from concept through production. Leads the development of manufacturing processes for new and existing products, including process flows, time studies, and product line development. Designs new tooling and fixtures, and modifications to existing tooling, as required by product modifications, process changes, manufacturing problems, etc. Plans and coordinates inspections for incoming tooling, fixtures, and/or equipment. Reviews process issues, engineering changes, product modifications, and product performance requirements with appropriate project personnel. Aids in the concept and development of advanced tooling models for production and R&D needs. Aids in the concept and development of turntables, shuttles, advanced fixtures, and other equipment for production and R&D needs. Ensures equipment assembly meets all predetermined specifications and safety requirements. Designs and executes process validations, including IQ, OQ, and PQ, in compliance with regulated and audited requirements and documented change control. Conducts risk assessments, including PFMEAs, and measurement system analyses (MSA/Gage R&R). Supports the manufacturing floor through sustainment practices that optimize uptime and address process variation issues. Develops and understands BOM cost structures. Identifies risk points in current customer-owned processes or BOMs, and manages and communicates countermeasures or plans. Cultivates strong, long-term relationships with key decision-makers within accounts and develops a deep knowledge of the customer organization. Works to continuously improve engineering standards, documentation, and practices, including CAD standards, strengthening their professionalism and credibility. Manages team resource planning to ensure success. A bachelor's degree in Mechanical, Manufacturing, Biomedical, or a related engineering discipline.

8+ years' manufacturing engineering experience with demonstrated progression in responsibility.

At least 1 year of management experience.

Experience in a regulated manufacturing environment, including process validation (IQ, OQ, PQ) and documented change control.

Hands-on experience developing manufacturing processes; Proficiency in SolidWorks preferred.

Experience with process flows, time studies, quoting, and tracking equipment budgets preferred.

Strong Microsoft Office skills; Ability to manage multiple tasks in a time sensitive demanding environment.