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)

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?

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Job Description:

6+ years of experience in life sciences and medical device industries, excelling in New Product Introduction (NPI), process development, equipment validation (IQ/OQ/PQ), test method validation (TMVs) and continuous improvement in GMP, FDA, and ISO 13485 environments driving process efficiency and compliance.

EDUCATION

• M.S., Engineering – preferred (but not required)
• B.S., Engineering – Could be Biomedical, Mechanical, Industrial, Manufacturing, Aerospace

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 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…