TE
Mechanical Engineer (medical devices)
Accepting applicationsTechnosoft Engineering · Camarillo, CA
Full-Time Mid_senior
Posted
3d ago
Category
Manufacturing
Experience
Mid_senior
Country
United States
Technosoft Engineering successfully continuing over 25 years as superlative global provider of Digital Engineering & Consulting, Product Engineering, Manufacturing Engineering, Software Engineering and Data Analytics with substantial operations in India, North America and Europe. Established in 1999 as a division of 50 years old Technocraft Group, Technosoft serves clients in various industries, including Transportation, Industrial Products, Process Industry, Medical Equipment, Energy and Furniture. With a strong team of over 850 engineers and designers worldwide, Technosoft offers multi-disciplinary engineering services across its five business lines: Engineering, Consulting, R&D, Turnkey Automation Solutions, and Content Management. As a subsidiary of Technocraft Group, a $350 million Indian conglomerate, Technosoft has a solid foundation and global reach, supporting clients worldwide.
Currently we are looking to expand our team and looking for this resource urgently. W2 / Corp-corp /1099 / (H1 transfer accepted)
Technosoft Offers the best of the best benefits:
Competitive compensation based on skills
Industry leading health, dental, and vision plans
Relocation Assistance
PTO’s (Paid time off)
Generous 401 (K) savings and profit sharing
Education assistance and internal training programs.
Maternity & paternity leave.
Flexible Work Schedule where you will work with your manager to enjoy a work schedule that can be flexible with your personal life.
Interested in learning more on our robust benefits package we offer?
_________________________________________________________
RELEVANT EXPERIENCE
Sr. Manufacturing Process Engineer – New Product Introduction (NPI)
Led process development and process optimization of semi-automated equipment using Design of Experiments (DOE), statistical analysis and control charts (Minitab) to improve yield by 23%
Authored comprehensive technical documentation including URS, IQ/OQ/PQ, SOPs, MPIs, Engineering Reports, BOMs, and Work Instructions in support of GMP/FDA/ISO 9001 compliance
Created and validated functional and destructive Test Methods; conducted Test Method Validation (TMV)-Attribute and Variable using Gage R&R to ensure high reliability and repeatability
Executed Sterilization Validation (EO/Gamma) for subassembly level components per ISO standards and regulations
Collaborated cross-functionally with R&D, Quality, Supply Chain, and Suppliers to develop material specifications for raw materials, subassemblies, and finished goods
contributing to a 15% reduction in material non-conformances and improved first-pass yield.
Designed tooling and fixtures in SolidWorks, driving production efficiency, cost reduction, and improved throughput by identifying bottlenecks and reduced scrap rate by 15%
Managed facility expansion projects, performing impact/risk assessments, coordinating equipment calibration, preventive maintenance, and equipment qualification for seamless integration
Supported DFM activities and Design Verification & Validation (V&V) builds for New Product Introductions (NPI), ensuring manufacturability and quality from concept through scale-up
Spearheaded technology transfer of capital equipment that increasing operator efficiency by 30%, moving from single-pill to multi-pill packaging and managing validation activities
Engineered and supported manufacturing of injection-molded plastic and silicone components by introducing and optimizing capital equipment, leveraging strong GD&T knowledge to interpret detailed mechanical drawings and ensure design intent
Conducted and maintained pFMEAs, cycle time, and yield analyses, leading to a 20% reduction in equipment downtime
Drove compliance by partnering with Quality to ensure GxP alignment; owned ECOs/DCOs for process changes via QMS-PLM (Arena)
TECHNICAL SKILLS
Manufacturing & Quality: DOE, Gage R&R, SPC, ANOVA, TMV, GMP, IQ/OQ/PQ, CAPA, pFMEA, Aseptic Manufacturing, Root Cause Analysis (5 Whys, Fishbone), Sterilization (EO, Gamma), Injection Molding, Thermoforming, Serialization, Packaging
Tools & Software: Microsoft Office, Minitab, JMP, SolidWorks, Visio, SAP ERP, MES, Arena, JIRA, Agile, Windchill, Microsoft ProjectMethods & System: Lean Manufacturing, Six Sigma (DMAIC), 5S, A3, 8D, PDCA, Gemba Walk, VSM
Project & Program Management: Project Management, Team Management, Project Planning, Stakeholder Communication, Risk Management, Budget Management, RACI Matrice
________________________________________________
At Technosoft Engineering we are dedicated to building a diverse, inclusive and authentic workplace, so if you’re excited about this role but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right person for this or other roles.
For more Information please feel free to reach us:
bchakraborty@technosofteng.com
Show more Show less
Currently we are looking to expand our team and looking for this resource urgently. W2 / Corp-corp /1099 / (H1 transfer accepted)
Technosoft Offers the best of the best benefits:
Competitive compensation based on skills
Industry leading health, dental, and vision plans
Relocation Assistance
PTO’s (Paid time off)
Generous 401 (K) savings and profit sharing
Education assistance and internal training programs.
Maternity & paternity leave.
Flexible Work Schedule where you will work with your manager to enjoy a work schedule that can be flexible with your personal life.
Interested in learning more on our robust benefits package we offer?
_________________________________________________________
RELEVANT EXPERIENCE
Sr. Manufacturing Process Engineer – New Product Introduction (NPI)
Led process development and process optimization of semi-automated equipment using Design of Experiments (DOE), statistical analysis and control charts (Minitab) to improve yield by 23%
Authored comprehensive technical documentation including URS, IQ/OQ/PQ, SOPs, MPIs, Engineering Reports, BOMs, and Work Instructions in support of GMP/FDA/ISO 9001 compliance
Created and validated functional and destructive Test Methods; conducted Test Method Validation (TMV)-Attribute and Variable using Gage R&R to ensure high reliability and repeatability
Executed Sterilization Validation (EO/Gamma) for subassembly level components per ISO standards and regulations
Collaborated cross-functionally with R&D, Quality, Supply Chain, and Suppliers to develop material specifications for raw materials, subassemblies, and finished goods
contributing to a 15% reduction in material non-conformances and improved first-pass yield.
Designed tooling and fixtures in SolidWorks, driving production efficiency, cost reduction, and improved throughput by identifying bottlenecks and reduced scrap rate by 15%
Managed facility expansion projects, performing impact/risk assessments, coordinating equipment calibration, preventive maintenance, and equipment qualification for seamless integration
Supported DFM activities and Design Verification & Validation (V&V) builds for New Product Introductions (NPI), ensuring manufacturability and quality from concept through scale-up
Spearheaded technology transfer of capital equipment that increasing operator efficiency by 30%, moving from single-pill to multi-pill packaging and managing validation activities
Engineered and supported manufacturing of injection-molded plastic and silicone components by introducing and optimizing capital equipment, leveraging strong GD&T knowledge to interpret detailed mechanical drawings and ensure design intent
Conducted and maintained pFMEAs, cycle time, and yield analyses, leading to a 20% reduction in equipment downtime
Drove compliance by partnering with Quality to ensure GxP alignment; owned ECOs/DCOs for process changes via QMS-PLM (Arena)
TECHNICAL SKILLS
Manufacturing & Quality: DOE, Gage R&R, SPC, ANOVA, TMV, GMP, IQ/OQ/PQ, CAPA, pFMEA, Aseptic Manufacturing, Root Cause Analysis (5 Whys, Fishbone), Sterilization (EO, Gamma), Injection Molding, Thermoforming, Serialization, Packaging
Tools & Software: Microsoft Office, Minitab, JMP, SolidWorks, Visio, SAP ERP, MES, Arena, JIRA, Agile, Windchill, Microsoft ProjectMethods & System: Lean Manufacturing, Six Sigma (DMAIC), 5S, A3, 8D, PDCA, Gemba Walk, VSM
Project & Program Management: Project Management, Team Management, Project Planning, Stakeholder Communication, Risk Management, Budget Management, RACI Matrice
________________________________________________
At Technosoft Engineering we are dedicated to building a diverse, inclusive and authentic workplace, so if you’re excited about this role but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right person for this or other roles.
For more Information please feel free to reach us:
bchakraborty@technosofteng.com
Show more Show less