The Manufacturing Engineer is responsible for driving continuous process improvement in the manufacturing process through efficiencies: minimize down time, improve throughput, and minimizing waste.
Scope:
- Exercises technical leadership support and analytical skills in the resolution of production issues including root cause analysis.
- Prepares technical reports, drafts and executes validations and change control under the direction of Manufacturing Engineering management staff.
- Apply DOE and statistical tools to identify root cause(s) of yield loss and propose and implement corrective actions, make recommendations for changes in test fixtures or test methods by applying theory & principles of mechanical engineering.
- Maintain Work Instructions, BOM’s, preventative maintenance schedules, and routers and perform training as required.
- Confer with engineering staff and submit reports of test results to engineering department and recommend design or material changes.
- Actively participate in discussions related to changes in design, method of manufacture and assembly, and drafting techniques and procedures with staff and coordinate corrections.
- Develop and release processes and equipment in a controlled manner, ensure documentation procedures have been followed and drawings are accurate.
- Draft and execute validation & verification for tooling, equipment, and processes, including IQ/OQ/PQ organized activities.
- Identify and resolve manufacturing errors expeditiously with attention to impact on safety/ergonomics, quality, cost and production schedules.
- Actively participate on new product release teams from the earliest phases to assure that design for manufacturing concepts are employed and to facilitate a smooth transition from Engineering to Manufacturing.
- Owns the development of assembly processes for new products as well as the introduction of new methods into the assembly processes of current products and associated PFMEA’s.
- Interpret engineering prototypes, test instructions, drawings, and schematics to identify, modify and plan requirements for fabrication, assembly, testing and test nature of technical problems.
- Devise, document, fabricate and assemble new or modified test fixtures for construction by the machine shop or external supplier.
- Perform other work-related duties as requested, directed or assigned by management.
Requirements:
- BS in Mechanical, Industrial, Manufacturing, or Biomedical Engineering required.
- 2+ years of experience in regulated manufacturing environment.
- Proficiency in 3D Modeling required, SolidWorks preferred
- Experience in electronics and systems design a plus
- Proficient in CAD Modeling and knowledgeable in drawing standards/GD&T
- Requires understanding of validation concepts and document control.
- Ability to manage multiple projects in a fast paced & dynamic environment
- Knowledge of additive manufacturing techniques a plus.
#Onsite
This position offers a salary and full health, 401k and fringe benefits, target salary is ideally between 65k - 90k dependent on a number of factors. This is an onsite position. This position may be eligible for additional incentive bonuses.
