
Principal Design Engineering Specialist
7 days ago
Key Responsibilities:
- Conduct thorough assessments of medical device regulations and execute gap analyses, manufacturing print reviews, and remediation activities.
- Apply expertise in product sustenance engineering with a focus on design, manufacturing, production processes, and regulatory compliance.
- Coordinate effectively with suppliers to resolve technical queries, ensuring timely and high-quality project delivery.
- Communicate effectively with cross-functional teams to drive collaboration, technical reviews, and achieve project goals.
- Develop 2D/3D drawings/models for assemblies and components (such as plastics/metals/packaging) in compliance with ASME standards, utilizing expertise in GD&T.
- Utilize good understanding of DFM and DFA principles along with different manufacturing methods.
- Conduct, review, and update models for tol-stackup studies and dimensional variation analysis (1D/2D) using Creo-CETol or other tools.
- Manage CAD data and change orders using windchill/agile PDM.
- Participate in ideation activities to assess project scoping and viability through economic analysis, conflict analysis, and supplier quote validation.
- Work independently with minimal supervision, taking the initiative to determine and develop effective solutions.
- Apply project management skills to plan, schedule, and monitor project activities efficiently ensuring FTR & OTD excellence.
- Conduct root cause analysis to resolve design and process issues.
Required Skills and Qualifications:
- Bachelor's degree in mechanical engineering with 6-8 years of relevant experience.
- Proficiency in Creo and Solid Works (drafting and modeling), with hands-on experience in PLM/PDM preferably Windchill.
- Strong verbal and presentation skills for effective collaboration with global teams.
- Well-versed in MS Powerpoint, Excel for reports preparation, data analysis, and advanced operations.
- Experience in creating production drawing using GD&T.
- Tol-stack up (1D/2D/3D) studies for dimensional analysis using tools (excel, CETol).
- Experience in concept development and prototyping.
- DFMEA, PFMEA, and design control procedures.
- Project management skills to develop clear project plans, timelines, and milestones.
- Engineering Change Management and Sustenance Engineering.
- Understanding of Supplier Quote Validation.
- Good Manufacturing Knowledge for materials such as plastic, metals, packaging, and sheet metal.
Nice to Have:
- Medical Device Experience.
- Knowledge of electronics, cable, connectors, PCBA manufacturing methods.
- Should Costing and Quote Validation experience in materials like metals, packaging, and plastic.
- VAVE experience for cost-down project execution and certification (SAVE/INVEST).
- Exposure to PPAP deliverables.
- Six Sigma methodology (DFSS/DMAIC).
- Minitab, Statistical Analysis.
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