Website:
omicsveu.com
Job details:
Job Description
Role Overview
The Mechanical Design Engineer will be responsible for designing and developing innovative electro-mechanical instruments used in In-Vitro Diagnostics (IVD) and research applications. The role involves concept development, prototyping, validation, and collaboration with manufacturing and cross-functional teams to ensure reliable and regulatory-compliant product development.
Key Responsibilities
Design and develop electro-mechanical systems and diagnostic instruments for IVD and research applications.
Create innovative concepts, develop prototypes, and perform assembly and testing of mechanical systems.
Develop 3D models and drawings using PTC Creo, ensuring adherence to GD&T standards.
Conduct FEA simulations and tolerance stack-up analysis to validate design performance.
Perform root cause analysis (RCA) and corrective actions (CAPA) for design failures.
Support New Product Development (NPD) and sustaining engineering activities.
Implement DFM/DFA methodologies to optimize manufacturability and assembly efficiency.
Drive cost optimization initiatives (VAVE) and continuous product improvements.
Collaborate with suppliers and vendors to ensure quality component manufacturing.
Prepare and maintain technical documentation including DHF, DMR, ECO releases, and specification sheets.
Ensure compliance with industry standards such as ASME, ISO, FDA regulations, and medical device quality systems.
Work closely with cross-functional teams including manufacturing, validation, and reliability engineering.
Requirements
Requirements
Education
Experience
Technical Skills
Strong expertise in PTC Creo (mandatory)
Experience in FEA, tolerance stack-up analysis, GD&T
Knowledge of DFM, DFA, and manufacturing process optimization
Familiarity with Design Controls, Risk Management, ISO 13485, and ISO 14971
Experience working with ECO processes, DHF, and DMR documentation
Professional Competencies
Strong analytical and problem-solving capabilities
Ability to work in cross-functional engineering teams
Strong documentation and regulatory compliance awareness
Ability to prioritise tasks independently and meet project milestones
Benefits
Competitive salary and performance incentives
Opportunity to work on advanced diagnostic instrument development
Exposure to medical device product development and regulatory standards
Collaborative engineering environment with cross-functional teams
Career growth in medical diagnostics and instrumentation technologies
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