Job Title: Mechanical Design Engineer
Department: Engineering & Product Development
Location: Adibatla, Hyderabad
Job Summary:
BioGenex is seeking a skilled and innovative Mechanical Design Engineer to join our dynamic team. The ideal candidate will be responsible for the design, development, and optimization of electro-mechanical equipment and devices, ensuring compliance with industry standards and regulatory requirements. This role requires expertise in PTC Creo, Finite Element Analysis (FEA), and Design for Manufacturing & Assembly (DFM/DFA) methodologies.
Key Responsibilities:
- Machine Design & Development: Lead the design and development of electromechanical systems and devices.
- Concept & Prototyping: Conceptualize innovative designs, generate prototypes, and evaluate performance.
- Assembly & Testing: Oversee the assembly and testing of prototypes, ensuring functional reliability.
- Project Quality & Documentation: Ensure quality of project deliverables, maintain detailed documentation.
- PTC Creo Expertise: Create 3D models, detailed drawings, and assemblies using PTC Creo must.
- Component Specification: Prepare independent specification sheets for bought-out components.
- Cross-Functional Collaboration: Work with manufacturing, assembly, and cross-functional teams for seamless product integration.
- Task Prioritization: Self-initiate, prioritize, and direct tasks to achieve project milestones.
- Failure Analysis & CAPA: Conduct Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA).
- FEA & Tolerance Analysis: Perform Finite Element Analysis (FEA) and tolerance stack-up analysis.
- Cost Optimization: Implement Value Analysis & Value Engineering (VAVE) strategies for cost reduction.
- Manufacturing Process Optimization: Apply Design for Manufacturing (DFM) and Design for Assembly (DFA) methodologies.
- Process Improvements: Develop and implement enhancements in production and assembly processes.
- Validation & Reliability Engineering: Support product validation, testing, and reliability engineering activities.
- Technical Documentation: Prepare and manage technical documentation, including Geometric Dimensioning & Tolerancing (GD&T).
- Vendor & Supplier Coordination: Collaborate with suppliers and vendors for part manufacturing.
- Regulatory Compliance: Ensure compliance with ASME, ISO, FDA, ISO 13485, 21 CFR Part 820, EU MDR, and related standards.
- New Product Development (NPD) & Sustaining Engineering: Handle all NPD & sustaining tasks, releasing drawings and documents through Engineering Change Orders (ECOs).
- Risk Management & Design Controls: Apply principles of Design Controls, Risk Management (ISO 14971), and ISO 13485 in engineering processes.
- Product Documentation: Develop and maintain Design History Files (DHF) and Device Master Records (DMR).
Education & Qualifications:
- Required: B.E/B. Tech/M.E/ M.Tech/ MS in Mechanical Engineering.
Experience & Skills:
- 3-5 years of experience in mechanical design, electromechanical systems, or related fields.
- Strong knowledge of PTC Creo for 3D modelling, assemblies, and technical drawings.
- Hands-on experience in FEA, tolerance analysis, DFM/DFA, and VAVE.
- Expertise in risk management, failure analysis, and quality improvement methodologies.
- Working knowledge of ISO 13485, 21 CFR Part 820, EU MDR, and ASME standards.
- Ability to work in a cross-functional environment, collaborating with engineering, manufacturing, and quality teams.
- Strong analytical, problem-solving, and project management skills.
- Excellent communication and documentation skills.
Why Join BioGenex?
- Work on cutting-edge technologies in molecular pathology systems.
- Be part of a highly skilled team driving innovation in medical device engineering.
- Opportunities for professional growth and skill development.
Employment Type: Full Time, Permanent
Read full job description