JOB SUMMARY

Lead contract manufacturing projects from concept through production, ensuring robust process design, manufacturability, and ongoing improvement. Support production teams, drive continuous improvement, maintain compliant documentation, and collaborate directly with customers and cross-functional teams. Ensure all processes and specifications meet QMS, FDA 21 CFR Part 820, and ISO 13485 requirements.

PRINCIPLE RESPONSIBILITIES AND RESULTS

1. Contract Design & Development

• Lead design and development for OEM/contract manufacturing projects.
• Manage prototypes, first articles, design risk mitigation, and product testing.
• Apply DFM principles and create/maintain design documentation (DHF, DMR, V&V, FMEAs).
• Verify design outputs vs. inputs and support quality planning.
• Lead project timelines, milestones, and cross-functional meetings.

1. Contract Manufacturing Lead (OEM projects)

• Evaluate new or revised product designs for manufacturability and process fit.
• Work with OEM engineers to refine requirements and ensure production feasibility.

1. Manufacturing Process Development and Documentation

• Develop, validate, and document production processes for repeatability and efficiency.
• Design/validate tools, fixtures, molds, and work instructions.
• Conduct PFMEAs, process capability studies, and prototype builds.
• Train production personnel on new processes.
• Support and lead where required assessment and qualifications of suppliers.
• Support and lead where required sourcing and qualification of materials.

1. Continuous Improvement

• Apply Lean principles to reduce waste and improve efficiency.
• Lead/participate in root-cause investigations and corrective actions.
• Develop error-proofing tools, test new materials, and assess ROI for improvements.
• Implement changes through Change Control and CAPA.

1. Production Support
   • Resolve production issues, review documentation, and initiate updates.
   • Participate in NCR/MRB activities and help define acceptance criteria.

1. Other Duties
   • Represent Domico with professionalism
   • Travel as needed (domestic and international)
   • Champion Domico Med-Device, LLC vision, purpose, and values
   • All other duties, as assigned.

KNOWLEDGE, SKILLS, AND ABILITIES

Required Qualifications

• Bachelor's in Mechanical or Industrial Engineering (or equivalent experience).
• 5+ years in manufacturing/mechanical engineering and product development.
• Strong SolidWorks/EPDM skills; ERP experience (Global Shop preferred).
• Lean familiarity and strong analytical/problem-solving skills.
• Excellent communication and documentation skills.
• Highly organized, quality-focused, and collaborative.

Additional Preferred Qualifications

• Medical device experience.
• CNC programming experience.
• Technical writing experience.
• Compression Molding experience.

RELATIONSHIPS

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

Manufacturing Engineering Manager

Supervises (Title; FTE; # in position; note if providing work direction only)

This role is not a supervisory role

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

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.