Manufacturing Engineer; medical devices

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 Techno craft 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 Techno craft 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)

• 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?

• 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 Solid Works, 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)

• 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, Solid Works, Visio, SAP ERP, MES, Arena, JIRA, Agile, Windchill, Microsoft Project Methods & System:
  Lean Manufacturing, Six Sigma (DMAIC), 5S, A3, 8D, PDCA, Gemba Walk, VSM