Equipment Design & Process Development Engineer

About the Role (W2 Contract)

We are seeking a highly skilled Equipment Design & Process Development Engineer to lead the development of assembly and packaging equipment used across our manufacturing operations. This role will drive capital equipment projects from concept through site acceptance, collaborating closely with cross-functional teams, external suppliers, and internal engineering groups. The ideal candidate is an innovative mechanical or manufacturing engineer with strong CAD capabilities, hands-on project leadership experience, and deep knowledge of automated manufacturing processes.

Key Responsibilities

Equipment & Process Design

• Design assembly and packaging equipment to meet manufacturing needs and develop detailed User Requirements Specifications (URS).
• Develop and implement process designs for new production equipment.
• Optimize equipment for cost efficiency, changeover time, serviceability, and manufacturability.
• Perform engineering analyses to validate and refine designs.
• Ensure all designs meet safety, quality, and operational standards.

Project Leadership & Supplier Management

• Lead supplier relationships and manage external design teams for capital equipment programs.
• Select vendors, manage procurement, and ensure seamless equipment integration and commissioning.
• Oversee equipment development projects from requirements definition through validation and Site Acceptance Testing (SAT).
• Manage vendor contracts in collaboration with procurement and legal teams.

Technical Execution

• Create or obtain detailed 3D models and 2D drawings using CAD software.
• Collaborate with internal and external teams on automation and process optimization initiatives.
• Coordinate system integration with electrical and mechanical engineering groups.
• Support prototype development and testing activities.
• Analyze process performance and operational data to identify improvement opportunities.
• Provide technical support for production issues and ensure equipment uptime and serviceability.

Documentation & Compliance

• Develop and maintain comprehensive documentation including assembly instructions and bills of process.
• Lead and participate in design reviews, risk assessments, and FMEAs.
• Ensure compliance with internal quality policies, regulatory requirements, and applicable industry standards.
• Provide equipment-related cost estimates and technical inputs for business cases.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field.
• 5 years of experience in equipment design, process development, or automation engineering (medical device experience preferred).
• Proficiency with CAD software (e.g., SolidWorks, Creo, Inventor).
• Strong understanding of automated manufacturing equipment and process validation.
• Demonstrated experience managing capital equipment projects.
• Excellent communication, vendor management, and cross-functional collaboration skills.