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4 weeks ago
1. Primary Responsibilities:
- Receive RFQ Data from BD and Estimate the cost and prepare Quote to customer.( Wiring Harness).
- Design Control - Part number/BOM creation and Drawing sanitization
- DFM preparation -Assess complexity of design; required technology ; potential challenges.
- Prepare purchase specification & Detailed Manufacturing stagewise drawing
- Identify & develop special equipment / tooling /Fixture/Gauge requirement for New Projects.
- Layout, SOP/WI creation, PFD, CP, Check list ,PFMEA
- Proto build /Tool validation (IQ/OQ/PQ) ,Testing ,Improvements in product design and mfg process- Mechanical/Wiring Harness Assembly.
- Improvements in product design and mfg. process, Component Localization, Cost reduction
2. Knowledge and Skill Requirements:
- Strong knowledge of medical device regulations (ISO and GMP principles.
- Proven experience in process optimization and lean manufacturing methodologies.
- Excellent problem-solving skills and the ability to analyse data to make informed decisions.
- Leadership abilities to motivate and guide cross-functional teams.
- Proficiency in process mapping, root cause analysis, and corrective action implementation.
- Strong communication skills to effectively convey complex information to various stakeholders.
- Knowledge of Six Sigma methodologies is a plus.
- Experience with process validation and validation documentation is desirable.
3. Qualifications / Experience:
- Diploma or Bachelor's degree (Mechanical, Electrical, or related field) or equivalent
- Minimum 10 years of proven experience in Process Engineering.
