What are the responsibilities and job description for the Onsite Coordinator position at Katalyst CRO?
Job Description
Experienced Mechanical Design & Manufacturing Engineer with proven expertise in the design, development, and validation of plastic, casting, and sheet metal components including mold design. Adept at managing end-to-end product engineering operations from concept through manufacturing, ensuring design quality, manufacturability, and compliance with industry standards such as IP6X, UL, and IEC. Skilled in coordinating cross-functional teams, conducting feasibility reviews, and leading global collaboration for new product introduction.
Responsibilities
Experienced Mechanical Design & Manufacturing Engineer with proven expertise in the design, development, and validation of plastic, casting, and sheet metal components including mold design. Adept at managing end-to-end product engineering operations from concept through manufacturing, ensuring design quality, manufacturability, and compliance with industry standards such as IP6X, UL, and IEC. Skilled in coordinating cross-functional teams, conducting feasibility reviews, and leading global collaboration for new product introduction.
Responsibilities
- Lead design and development of mechanical systems including plastic, casting, and sheet metal components with focus on manufacturability and cost optimization.
- Prepare detailed manufacturing drawings, assembly instructions, BOMs, and engineering documentation (DHF, DMR, design change plans, impact analysis, etc.).
- Collaborate with hardware, firmware, verification testing, and mechanical design teams to ensure seamless integration of design requirements.
- Develop and track project requirements, plans, and timelines; conduct weekly engineering follow-up meetings with offshore and onsite teams.
- Drive Design Specification Reviews (DSR) with suppliers, ensuring adherence to technical, cost, quality, and schedule targets.
- Perform design feasibility assessments, DFMEA preparation, and verification/validation planning in compliance with medical design control processes.
- Coordinate prototype builds, verification testing, and supplier interaction for proof-of-concept (POC) manufacturing.
- Conduct tolerance stack-up analysis to validate design specifications and ensure functional performance.
- Collaborate with analysis teams on fluidic simulations, thermal studies, and finite element analysis (FEA).
- Ensure risk assessment and mitigation throughout the design lifecycle.
- Bachelor's or master's degree in mechanical engineering, Manufacturing Engineering, or related discipline.
- Proven experience in plastic, casting, and sheet metal component design, including mold design and manufacturability assessments.
- Strong understanding of engineering design processes, DHF/DMR documentation, and design control requirements (especially for regulated industries).
- Hands-on experience with CAD tools (e.g., Creo, SolidWorks, CATIA, or NX) and tolerance stack-up analysis.
- Familiarity with DFMEA, risk management, and verification/validation testing planning.
- Knowledge of IP6X/UL/IEC standards and compliance requirements.
- Proficiency in project management tools such as MS Project, and documentation tools such as MS Office (Word, Excel, PowerPoint).
- Excellent skills in cross-functional collaboration with hardware, firmware, and testing teams.
- Strong organizational, communication, and stakeholder management abilities for offshore/onshore coordination.
- Experience in supplier interaction, design reviews (DSR), and cost-quality-schedule optimization.
- Ability to manage multiple projects simultaneously under tight deadlines.
- Experience as CAPA Owner for engineering non-conformances.
- Exposure to supplier quality management and direct/indirect sourcing.
- Working knowledge of FEA, thermal, and fluidic simulations collaboration processes.