Associate Operations Manager
Stryker
PMP
Job Level
Mid-LevelSenior
Tech Stack
PMPPython
About the role
- Be a part of the Medtronic Engineering and Innovation center (MEIC) and support growth and development of Global supply management team within MEIC
- Collaborate closely with stakeholders and local and global counterparts to ensure timely and successful completion of assignments
- Individual contributor role leading medium to high complexity supplier transfers and programatic savings projects
- Focus on vertical integrations, localization, cost optimizations and supplier management assignments
- Perform design/engineering documentation gap assessments, manufacturing print reviews and remediation activities
- Participate in ideation workshops for project scoping and economic analysis and supplier quote validation
- Execute product sustenance engineering activities across design, manufacturing methods and regulatory compliance
- Coordinate with suppliers to resolve technical queries and ensure timely, high-quality project delivery
- Develop and refine detailed 2D drawings and 3D CAD models; perform reverse engineering to recreate CAD models and extract design intent
- Conduct DFMEA/PFMEA and design reviews; review and validate drawings for DFMA and manufacturability
- Review and validate PPAP reports and assess technical specifications
- Manage engineering change procedures using PDM/PLM tools (Agile, Windchill)
- Assist in developing Master Validation Plans, conduct MSA, and execute IQ/OQ/PQ studies and documentation
- Use Minitab and MS tools (Excel, PowerPoint) for statistical analysis, reporting and data analysis
Requirements
- Knowledge of medical device regulations (MDR,FDA,CE,IEC)
- Hands on expertise on design or engineering documentation gap assessments, manufacturing print reviews and remediation activities
- Participate in ideation workshops to assess project scoping and viability through economic analysis and supplier quote validation for programatic savings projects
- Experienced in product sustenance engineering activities with expertise across design, manufacturing methods (Stamping, Plastics, PDC parts), production processes and regulatory compliance
- Skilled in coordinating with suppliers to resolve technical queries
- Develop and refine detailed 2D drawings and 3D CAD models
- Hands-on experience in reverse engineering components using 3D scanning and advanced inspection techniques
- DFMEA/PFMEA and design reviews to assess and mitigate design & Mfg risks
- Review and validate engineering drawings for DFMA, Manufacturability, Accuracy and Completeness
- Review and validate PPAP reports received from supplier
- Well versed with Engineering Change management procedures using PDM/PLM Softwares (Agile, Windchill, etc.)
- Assist in developing Master Validation Plans, conducting MSA studies, preparing process flow, conducting and reviewing IQ,OQ and PQ studies and documentation
- Hands on expertise for Minitab to perform statistical analysis and studies
- Well versed with MS tools like excel, presentation for reporting and date analysis purpose
- Minimum of 6-8 years of relevant experience
- Bachelor of Engineering in Mechanical or Production engineering
- Good to have: Should costing experience (DFMA/aPriori) for metals, plastic and electronics components
- Familiarity with Six Sigma methodologies (DFSS/DMAIC/LSS)
- Knowledge of Lean Manufacturing principles
- VAVE experience for cost down project execution and certification (SAVE/INVEST)
- GD&T Certification
- PMP trained/ Certified
- Advance degree (PG/Masters) in Plastics, Material, Tool design,etc
- Knowledge of PowerBI, Data analytics, Python for process automation
- Excellent interpersonal, influence management, and conflict resolution skills
- Strong written, verbal, and presentation skills
