Manufacturing Engineer II

Overview

We are seeking a Manufacturing Engineer II to support process development, continuous improvement, and new product introduction within a regulated, precision machining environment. This role is ideal for an engineer with strong GD&T expertise, hands‑on machining experience, and the ability to collaborate effectively across functions.

Position Overview

In this role, you will lead efforts to improve and stabilize manufacturing processes, support validation and NPI activities, and help ensure operational excellence across Quality, Delivery, Cost, Safety, and Morale. You will work closely with engineering, quality, production, and metrology teams to enhance manufacturability and drive technical improvements.

Key Responsibilities

• Improve, document, and stabilize manufacturing processes within a regulated environment (ISO/FDA).
• Lead root cause analyses and implement corrective and preventive actions.
• Apply lean manufacturing methods across machining, metal finishing, and secondary operations.
• Develop tooling, fixtures, and equipment to improve cost, throughput, and process capability.
• Support new product introduction, including material evaluations and validation activities (IQ/OQ/PQ).
• Oversee metrology workflows, including review of CMM/CNC measurement results (no programming required).
• Create and maintain standard work, work instructions, and technical documentation.
• Collaborate with design and cross‑functional teams to optimize manufacturability and support quoting for new business.

Qualifications

Required

• Bachelor’s degree in Engineering or a related technical field.
• Minimum of 4 years of experience in a regulated manufacturing environment (medical device, aerospace, or defense preferred).
• Expert‑level knowledge of GD&T and comprehensive blueprint interpretation.
• Background in precision machining operations; metals preferred. Plastics acceptable (excluding injection molding).
• Familiarity with CAD tools such as SolidWorks.
• Working knowledge of validation protocols and regulated documentation.
• Understanding of metrology practices and ability to oversee CMM/CNC measurement workflows.
• Strong communication, analytical, and cross‑functional collaboration skills.
• Demonstrated ability to provide functional leadership or mentorship.

Preferred

• Experience with metal finishing processes.
• Lean manufacturing experience.
• Prior involvement in DFM and new product introduction.