Job Title: Manufacturing / Process Engineer
- Department: Engineering / R&D / Quality
- Location: Coimbatore, India
- Experience: 3–7 years
- Industry: Medical Devices (Preferred)
- Tools & Systems: SolidWorks, Creo, CATIA, NX, AutoCAD, Teamcenter, Windchill, Agile, QMS tools
- Employment Type: Immediate or 15 days
Role Overview
The Sustenance Engineer supports both mechanical design/development and quality engineering activities across the product lifecycle. The role involves designing and developing mechanical components, products, and fixtures, while ensuring compliance with global medical device regulations through effective Quality Management System (QMS) implementation.The engineer will contribute to product development, manufacturing support, inspection, calibration, documentation, risk management, supplier quality, audits, and continuous improvement initiatives. Collaboration with cross-functional teams is essential to ensure robust designs, regulatory compliance, efficient manufacturability, and high-quality outputs.
Key Responsibilities
- Lead the design and development of mechanical components, products, assemblies, jigs, fixtures, and test fixtures using advanced CAD tools; convert product requirements into detailed 3D models, 2D drawings, specifications, and engineering documentation.
- Conduct design analyses including GD&T, tolerance stack-up, material selection, structural assessments, and engineering calculations; perform feasibility studies, simulations, prototyping, and participate in structured design reviews.
- Collaborate closely with manufacturing teams to ensure DFM/DFA compliance, support prototype and pilot builds, resolve manufacturing issues, and drive root cause analysis, corrective actions, and continuous improvement.
- Prepare comprehensive technical documentation including assembly instructions, SOPs, work instructions, calibration guidelines, inspection criteria, measurement methods, and metrology requirements.
- Support inspection, calibration, and maintenance of gauges, tools, and production equipment.
- Execute re-engineering, reverse engineering, and value engineering initiatives to enhance product performance, reduce cost, and improve manufacturability while maintaining complete engineering documentation, DHFs, test reports, and revision-controlled records in PLM systems.
- Implement, maintain, and continuously improve the Quality Management System (QMS) in compliance with ISO 13485, ISO 14971, FDA, EU MDR, and other applicable global standards.
- Develop and harmonize controlled documents, SOPs, work instructions, and templates.
- Drive regulatory and quality compliance through gap assessments, remediation planning, process standardization, document control, version traceability, archival management, and adherence to Good Documentation Practices (GDP).
- Participate in risk management activities including FMEA, hazard analysis, identification of risk controls, and verification of effectiveness across product and process life cycles.
- Lead non-conformance investigations, perform root cause analysis, drive CAPA implementation, and support manufacturing quality activities such as inspection planning, process controls, in-process checks, and production quality investigations.
- Coordinate with suppliers for qualification, performance monitoring, audits, corrective actions, and continuous improvement initiatives to ensure supply chain quality and compliance.
- Collect, analyze, and report quality metrics, trends, and performance indicators to support data-driven decision-making and management reviews.
- Support internal, supplier, external, and regulatory audits including preparation, documentation, evidence collection, and closure of audit findings.
Required Skills & Qualifications
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- 3–7 years of combined experience in mechanical design, product development, and/or quality engineering roles.
- Strong understanding of:
- ISO 13485, EU MDR, FDA 21 CFR Part 820
- ISO 14971 and risk management methodologies
- QMS implementation, documentation, and audits
- CAPA, RCA, and non-conformance handling
- Supplier quality processes and calibration practices
- Hands-on experience with CAD tools (SolidWorks, Creo, NX, CATIA), PLM systems, and QMS platforms.
- Knowledge of DFM/DFA, GD&T, tolerance analysis, material selection, and manufacturing processes.
- Experience in medical devices or other regulated industries is preferred.
- Strong analytical, documentation, communication, and cross-functional collaboration skills.
Key Competencies
- Strong mechanical design, analysis, and problem-solving capability
- Quality mindset with expertise in compliance and process control
- Effective stakeholder communication and collaboration
- High attention to detail and documentation accuracy
- Ability to manage multiple priorities in regulated environments
- Continuous improvement and data-driven decision-making
