Manufacturing Engineer

JOB SUMMARY

Drive continuous improvement efforts to increase efficiency and lower potential for scrap. Ensure manufacturing processes are accurate and appropriate for converting engineering design specifications to a product that achieves customer requirements; coordinate cross functionally as appropriate. Support personnel on any production related issues such as processing problems or document non-conformances. Develop, document and utilize proven manufacturing processes; conduct and document process capabilities as appropriate. Support and or engage in direct communication with customers to understand product to improve design for manufacturability and align process capability. 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

1. Continuous Improvement Use LEAN Manufacturing principles and other methods to identify and implement cost savings and efficiency gains to existing Domico processes and products.
   • Collaborate with operators through observation and hands on problem solving on identified issues.
   • Contribute in root cause problem solving for internally or externally identified product issues.
   • Design tooling or aids to make processes error proofed, more efficient and consistent.
   • Identify, test and qualify replacement materials.
   • Implement changes via the Change Control and Corrective and Preventative Actions processes.

1. Production Support Work directly with production personnel to address issues found while making product.
   • Review drawings, routers, and work instructions with production, identify errors and provide redlines that will drive change requests.
   • Participate in the Non-Conformance Review (NCR) and Material Review Board (MRB).
   • Support the creation of acceptance criteria for Domico product families.

1. Product Design Support Contribute manufacturing process knowledge and experience to ensure requirements such as tolerances, fit, finish, etc. are compatible with our process capability. 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 Domico Med-Device processes, identify concerns for manufacturability and recommend solutions/alternatives; support the estimating process as appropriate.
   • Collaborate with cross-functional team to understand and or refine product requirements with the objective of achieving manufacturability (design for manufacturing DFM).
   • Collaborate with cross-functional team in creating design failure modes and effects analysis (DFMEA) and risk review. 
   • CAD design and detail work to convert design inputs to product specifications.

1. Manufacturing Process Development and Documentation Optimize production processes to assure repeatability, reliability, and efficiency.   Examples of this work include but are not limited to:
   • Engage with manufacturing subject matter experts to promote successful production integration.
   • Develop proficiency with manufacturing equipment, write programs to optimize performance.
   • Determine, document and validate process capability, including initial proof of concept/prototype build.
   • Design, verify, and when appropriate, validate production tools, molds, and fixtures including process work instructions and equipment file creation.
   • Collaborate with cross-functional team in creating process failure modes and effects analysis (PFMEA) and risk review. 
   • Train manufacturing personnel on process work instructions and requirements when necessary.

1. Other Duties 
   • Live by and promote the Domico Med-Device, LLC’s vision, purpose, and values.
   • Adhere to Domico Med-Device processes.
   • When necessary, manage multiple priorities.
   • Demonstrates a high level of professionalism, discretion and confidentiality with all tasks, especially when dealing with employees, customers, visitors, vendors, and members of the public.
   • Provide support and constructive feedback to co-workers including production personnel in a professional and polished manner.
   • Adhere to safety policies and procedures and promote a safe work environment for co-workers, customers, and suppliers.
   • All other duties, as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

KNOWLEDGE, SKILLS, AND ABILITIES

Required Qualifications

• Bachelor’s degree in mechanical or industrial engineering or proven experience in lieu of degree.
• Experience with SolidWorks or equivalent. 
• Proficiency in Microsoft Word and Excel.  
• Solid communication skills (verbally and in writing) and able to interface well with both technical and non-technical staff in various departments.
• Displays a focus on quality work and is results-oriented.
• Team player attitude with the ability to work constructively with other disciplines.    
• Proficient in problem-solving skills. 
• Ability to think analytically.
• Ability to organize workload and manage time effectively.

Additional Preferred Qualifications

• 2+ years of experience in manufacturing or mechanical engineering.
• Exposure to EPDM or equivalent. 
• Experience with ERP systems, Global Shop preferred.
• Technical writing experience.
• Familiarity in the development of engineering and manufacturing processes.
• Familiarity with Lean manufacturing principles.
• Experience with medical devices.
• Experience with CNC programming.

RELATIONSHIPS

This Position Reports to (provide class title, not person’s name):

Manufacturing Engineering Manager or Senior Manufacturing Engineer Lead

Internal and External Clientele and Purpose of Contact (the most significant job related contacts)

• All employees of Domico – Necessary for the cross functional interaction
• Customers, vendors, visitors, job candidates – Necessary for doing business outside of Domico

PHYSICAL DEMANDS & WORK ENVIRONMENT

This position will be required to frequently sit, utilize hand and finger dexterity, talk, and hear. This position requires the incumbent to frequently walk. The incumbent may occasionally be required to lift up to 35 pounds. This position sits in our Fenton, MI location and is an in-person role without any hybrid or remote options as this role heavily works with the production floor including desk-based work and production floor work where they could be coming up with continuous improvements, creating prototypes, or working with SMEs to overcome Engineering challenges. 

This work environment for this position is generally in a quiet office setting but is also required to be on the production floor which is a light manufacturing environment.