Fenton, MI 48430
- Ensure engineering documentation and manufacturing processes are accurate and appropriate for converting engineering design specifications to a product that achieves customer requirements; coordinate cross functionally as appropriate.
- Develop, document and utilize proven manufacturing processes; conduct and document verification and validation processes as appropriate.
- Utilize CAD to accurately document product or process specifications that are necessary to achieve design requirements.
- Support and or engage in direct communication with customers to understand product to improve design for manufacturability and align process capability.
- Analyze changes for feasibility and impact on specifications; implement approved changes as appropriate.
- Control product and process specifications to comply with quality management system (QMS), FDA 21 CFR Part 820, and ISO 13485 requirements.
PRINCIPLE RESPONSIBILITIES AND RESULTS**
- Product Design Support Contribute manufacturing process knowledge and experience to ensure requirements such as tolerances, fit, finish, etc. Are compatible with our process capability; assure cost estimates are accurate. Examples of this work include, but are not limited to:
- Evaluate new products or proposed changes to existing products to confirm material requirements are compatible with Company process, identify concerns for manufacturability and recommend solutions/alternatives; support the estimating process as appropriate;
- Participate or lead meetings (phone, video, or onsite) to understand and or refine product requirements with the objective of achieving manufacturability
- Utilize CAD to create or edit designs and details to achieve a documentation package that can be understood and utilized by Manufacturing, Quality, Purchasing, and Sales.
- Manufacturing Process Development and Documentation Optimize production processes to assure repeatability, reliability, and efficiency. Examples of this work include but are not limited to:
- Determine and document process capability
- Document production processes, document engineering masters in ERP system
- Design, verify, and when appropriate, validate production tools, molds, and fixtures;
- Determine sequence of operations, parts, tools and work instructions needed in order to achieve manufacturing goals according to product specifications; apply error proofing methods
- Conduct and document process failure modes and effects analysis (PFMEA)
- Engage with manufacturing subject matter experts to promote successful production integration
- Develop proficiency with manufacturing equipment, write programs to optimize performance
- Train manufacturing personnel on process work instructions and requirements
- Continuous Improvement Assess products and manufacturing processes to identify, evaluate, and implement improvements to product quality and costs.
- Utilize data to identify priorities to focus efforts for improvement
- Utilize Lean Manufacturing tools to achieve manufacturing efficiency, improve quality, reduce scrap, increase yield, and reduce lead-times or cycle-time through the development of new processes, optimizing work flows, space requirements, and equipment layouts.
- Collaborate with cross functional team members and as appropriate customers to implement improvements
- Bachelors degree in mechanical or industrial engineering or proven experience in lieu of degree.
- 5+ years-experience in manufacturing or mechanical engineering is preferred, experience with medical devices is beneficial.
- Familiarity in the development of engineering and manufacturing processes.
- Familiarity with Lean manufacturing principles.
- Extensive experience with CAD (Preferred SolidWorks) and EPDM or equivalent is required.
- Experience with CNC programming is desirable.
- Technical writing experience is desirable.
- Proficiency in Microsoft Word and Excel.
- Must possess solid communication skills (verbally and in writing) and able to interface well with both technical and non-technical staff in various departments.
- Possess excellent problem-solving skills.
- Ability to organize work load and manage time effectively.
- Ability to think analytically.
- Displays a focus on quality and being a results-oriented individual.
- Team player attitude with the ability to work constructively with other disciplines