
Product Development Expert
6 days ago
Job Title:
Product Engineering SpecialistAs a Product Engineering Specialist, you will be responsible for applying your knowledge of medical device regulations to execute gap assessments, manufacturing print reviews and remediation activities. You will work with cross-functional teams to drive collaboration, technical reviews and achieve project goals.
Key Responsibilities:
- Apply knowledge of medical device regulations and execute gap assessments, manufacturing print reviews and remediation activities.
- Experienced in product sustenance engineering activities with expertise across design, manufacturing, production processes and regulatory compliance. Skilled in coordinating 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.
- Prepare 2D/3D drawings/models for assemblies and components (such as plastics/metals/packaging) in compliance with ASME standards, with expertise in GD&T.
- 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.
- Should be able to use windchill/Agile PDM to manage CAD Data and change orders.
- 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 & presentation skills for effective collaboration with global teams.
- Well versed with MS Powerpoint, Excel for reports preparation, data analysis/advance 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 & prototyping.
- DFMEA , PFMEA and design control procedures.
- Project management skills to develop clear project plans, timelines, and milestones
- Engineering Change management & sustenance engineering
- Understanding of Supplier quote validation
- Good manufacturing knowledge for materials such as plastic, metals, packaging & sheet metal.
Nice to Have:
- Medical Device Experience
- Knowledge of electronics, cable, connectors, PCBA manufacturing methods.
- Should costing & quote validation experience in materials like metals, packaging &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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