What are the responsibilities and job description for the Production Process Engineer position at Katalyst CRO?
Company Description
Responsibilities:
All your information will be kept confidential according to EEO guidelines.
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Responsibilities:
- Support planning and execution for a relocation process from Plant A in Shanghai to Plant B in PA. Assess the needs, create detailed planning, ensure facility preparation, equipment disassembly and transport, and reassembly/optimization at new facility.
- Initiates Design for Lean Manufacturing in PDLM processes.
- Accountable for Process Requirements based on Product Specifications from I&D and Manufacturing Requirements.
- Accountable for process and equipment capability that meets Requirements.
- Applylean manufacturing principles. Orchestrates design for lean manufacturing with according inputs to PDLM workflows.
- Responsible for MF BOM, routing Master data towards release.
- EstablishInspection and Test Criteria for Philips owned components and assemblies
- Implementdesign changes in Philips factories and at suppliers driven by PDLM governed projects.
- Responsible for resources, planning, quality and cost.
- Executes the processes and standards in adherence to compliance with safety, regulatory and environmental requirements as well as local laws, companyGeneral Business principles and other policies.
- Bachelor’s degree or above in Mechanical, Industrial, Manufacturing Engineering, or related field.
- 5 years of experience in manufacturing, product development, or industrial engineering in relevant domains, like consumer electronics product or medical device.
- Proficiency in CAD software (SolidWorks, AutoCAD) and manufacturing simulations.
- Strong knowledge of Lean Manufacturing, Six Sigma, FMEA, and statistical process control (SPC).
- Excellent problem-solving, communication, and project management skills.
- Good knowledge on QMS (quality management system), like ISO9001, ISO13485, etc.
- Familiarity with automation manufacture, robotics, and ERP/MES systems is plus.
All your information will be kept confidential according to EEO guidelines.