Manufacturing Engineer II

Manufacturing Engineer II is a mid-level engineering role responsible for developing, validating, and improving manufacturing processes used in the production of medical devices. The individual will work cross-functionally with R&D, Quality, Operations, and Product Management to ensure robust, efficient, and compliant manufacturing operations. This role is expected to take ownership of projects, mentor junior team members, and contribute to the continuous improvement of processes and product quality.

• Develop and optimize manufacturing processes to improve quality and increase throughput through waste reduction risk prevention.
• Manage New Product Development (NPD) projects
• Generate full production documentation packages for Milling (3/5-axis), Swiss, and/or Metal Additive Mfg. methods.
• Uses Process Capability (Cp/Cpk) and Statistical Process Control (SPC) to ensure stable production.
• Independently lead moderate-scope projects supporting larger, cross-functional initiatives.
• Design, source, and implement fixtures, gages, molds, and tooling.
• Perform root cause analysis and corrective action planning related production issues.
• Analyze and interpret engineering drawings and specifications for manufacturability (DFM).
• Participate in process validations (IQ/OQ/PQ) and contribute to protocol generation and reporting.
• Provide technical input during design reviews for new products and design changes.
• Collaborate with machinists, technicians, and quality inspectors to resolve shop floor challenges.
• Assist in the development and refinement of SOPs, work instructions, and training materials.
• Participate in vendor selection and evaluation for outsourced manufacturing and tooling.
• Review and disposition Process Change Requests (PCR).
• Prepare project documentation and reports in compliance with QMS.
• Identify opportunities for new capital equipment to reduce costs or increase capacity.
• Utilize a risk-based approach to manufacturing using Lean/Six Sigma tools (PFMEA, Pugh, etc.)
• Mentor or support Manufacturing Engineer I team members, as needed.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 3–7 years of experience in a manufacturing engineering role, preferably in a medical device or regulated industry.
• Strong understanding of machining processes (CNC, EDM, milling, turning) and shop floor troubleshooting. Additive manufacturing experience a plus.
• Proficiency in Solid Works or equivalent CAD software; capable of designing tooling and fixtures.
• Demonstrated experience with Mfg. NPD, DFM principles, GD&T, and reading complex prints and models.
• Working knowledge of quality systems, ISO 13485, and FDA regulations, 21 CFR 820.
• Hands-on experience with process validations, risk analysis (PFMEA), and statistical methods (DOE).
• Strong analytical skills and problem-solving abilities; ability to manage multiple priorities.
• Clear verbal and written communication skills and ability to work cross-functionally.
• Proficiency with Microsoft Office and familiarity with ERP or PLM systems.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ability to stand, walk, climb, crouch, push, pull, and lift occasionally (up to 50 lbs).
• Regular use of hands and eyes for computer-based design and documentation tasks.

Occasionally required to work in a manufacturing environment, exposed to noise, fumes, and moving machiner