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 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?

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.

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