Job Summary:
The manufacturing engineer for fabrication processes is responsible for designing, scaling, and optimizing metal fabrication and metalworking processes used within medical device assemblies to ensure consistent, high-quality production. Develops fabrication programs and processes, including tooling and fixtures, while implementing robust process controls aligned with PFMEA and GMP requirements in a low-volume, high-mix manufacturing environment. Serves as a technical liaison for customer design transfers, supports validation activities, and drives continuous improvement initiatives to enhance efficiency and reduce costs. Provides mentoring and training to production personnel, and acts as a subject matter expert in troubleshooting, CAPA, and GMP process compliance.
Essential Duties and Responsibilities:
-
Define, program, and optimize metal fabrication and machining processes for fabricated subassemblies that will be used in medical device electro-mechanical assemblies, including converting 3D models and drawings into flat patterns with appropriate bend deductions and allowances.
-
Develop and maintain work instructions, process flows, handling and maintenance requirements, quality checklists and technical drawings, while identifying opportunities to improve efficiency, throughput and overall process capability.
-
Establish and maintain PFMEA-aligned assembly process controls to support successful product launches and design transfers. Define ERP BOM structures and develop assembly documentation in compliance with GMP requirements.
-
Provide technical support and troubleshooting during prototype builds, production, tooling, and process validation activities, including IQ/OQ/PQ as required.
-
Drive process development and scale-up efforts, including the design, programming and program control, procurement and fabrication of tools, tooling library management fixtures, gauges, and equipment to enable controlled, repeatable metal fabrication and metalworking fabrication processes.
-
Serve as a technical lead when interfacing with customers, supporting product transfer efforts, tolerance and manufacturability reviews, and the implementation of customer-specific requirements.
-
Provide technical support to production including training and mentoring fabrication personnel and quality teams on established processes.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.
Education
-
A degree in a technical field such as Mechanical, Manufacturing, or Industrial Engineering, or equivalent relevant experience.
Experience and/or Training
-
Minimum of 2 years of experience, or an equivalent combination of education and relevant fabrication manufacturing experience in fabrication manufacturing processes such as laser cutting, turret punch, welding, hardware insertion, metal finishing, and/or press brake, etc.
-
Proficient with SolidWorks, ProE, AutoCAD, or other CAD software.
-
Proficient in power tools, hand tools, precision measurement instruments.
-
Proficient in interpreting and creating engineering drawings, technical documentation, and specifications.
-
Proficient with SolidWorks, ProE, AutoCAD, or other CAD software.
-
4i Blank and Form Programming Software, Influent and SigmaNest (preferred)
-
Experience using root cause and problem-solving methodologies (DMAIC, 5 Whys, Fishbone, etc.).
-
Working knowledge of ISO 9001 & 13485 Quality System requirements.
-
Knowledge of FDA regulations is preferred.
-
Experience supporting continuous improvement initiatives.
-
Six Sigma Green Belt or Black Belt certification (preferred).
-
Proficiency in Microsoft Office Suite.
Physical and Mental Demands
-
Frequent prolonged standing and sitting standing and walking in office, manufacturing, warehouse, or operational environments.
-
Occasional bending, reaching, climbing stairs, and light lifting (up to 40 lbs., if applicable).
-
Visual acuity to review data, analyze reports, and observe operational processes, with color perception required.
-
High level of analytical thinking and problem-solving to evaluate complex processes and identify root causes.
-
Ability to interpret data, metrics, and financial impact analyses to drive decisions.
-
Ability to manage multiple projects simultaneously with shifting priorities.
-
High attention to detail with strong organizational skills.
-
Effective communication skills, including presenting to customers and frontline teams.
-
Resilience and adaptability in dynamic operational settings.
-
Ability to receive and provide instructions in a positive manner.
-
Willing to work across all locations and alter hours as to ensure continuous support for projects and production as needed.
-
Flexible to change and possess a high degree level of integrity and “can do attitude”.
The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
Work Environment
-
Primarily office-based work with frequent presence in a production environment. While in the production facility, exposure to moderate to loud noise levels and non-climate-controlled conditions may occur.
