Manufacturing Engineer

KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

• Strong technical skills in project management and capital budgeting
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• Experience leading end-to-end projects.
• Demonstrated problem-solving and data analysis abilities.
• Risk analysis and statistical analysis expertise.
• Ability to manage multiple priorities and work independently.
• Tooling design experience of assembly processes.
• Proficiency in Solid Works
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• Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts. Experience in an FDA regulated quality environment.

• Design assembly and packaging equipment and create user requirements specifications (URS) that meet manufacturing standards.
• Develop and implement process designs for new equipment.
• Lead supplier relationships and external design teams for capital projects.
• Create/obtain detailed 3D models/2D drawings using CAD software.
• Optimize equipment designs for cost efficiency, changeover time, maintainability and manufacturability.
• Perform engineering analyses to validate and optimize designs.
• Lead medical manufacturing process technology initiatives across all sites and products.
• Manage equipment development projects from requirements through implementation and site acceptance testing (SAT).
• Select vendors, manage procurement, and ensure successful equipment integration.
• Provide equipment and engineering cost inputs for business cases.
• Validate equipment designs meet safety and operational standards.
• Collaborate with suppliers on automation process optimization.
• Analyze process performance data from existing operations.
• Manage vendor contracts with procurement and legal teams.
• Develop innovative mechanical systems based on project requirements and industry standards.
• Create and maintain comprehensive design documentation including assembly instructions, bill of process, etc.
• Participate in design reviews and risk assessments.
• Build and maintain failure mode and effects analysis (FMEA).
• Collaborate on prototype development and testing.
• Coordinate with electrical and mechanical engineers for system integration.
• Provide technical expertise during production issues.
• Ensure compliance with BD quality policies, procedures, regulatory requirements and industry standards.
• Design equipment for efficient operations to meet production targets and quality standards.
• Ensure equipment uptime and serviceability.
• Deliver projects on time and within budget.

At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team‑orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity.

• Free Healthcare Insurance
• Vision and Dental Insurance
• 401(k) Retirement Plan
• Free Life Insurance
• Sick Time Off

Achieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like:

• Certifications
• Mentorship Program
• Referrals
• Family and Wellness benefits
• Continuous Growth and Career Development