Senior Mechanical Engineer

• Support the Chief Engineer with the design and development of invoX devices and associated manufacturing processes
• Provide medical device design expertise for successful design, development, and verification of invoX devices
• Establish and maintain design controls according to invoX SOPs and relevant regulatory guidelines
• Establish and maintain version control for devices in development and post-design freeze
• Lead CAD and PDM software use, including drawing standards and version/release control
• Manage and execute proof-of-concept activities through analytical models, calculations, and empirical testing
• Apply analytical methods appropriate to project stage and required accuracy
• Assess design intent of components and assemblies against manufacturing capability, quality, and cost
• Analyze requirements and design data to recommend suitable design solutions
• Create and tailor design reviews, presentations, and reports for manufacturers, managers, and clients
• Author and review design inputs such as requirements and DFMEAs
• Align design outputs such as specifications, CAD, BOMs, and release notes for manufacturing partners
• Write reports and documentation to a high standard
• Provide technical advice and troubleshoot issues using structured problem-solving tools such as 8D

Requirements

• Master in Mechanical Engineering
• Good understanding of medical device standards and essential requirements
• Hands on with a robust design process, preferably ICH QbD related to CFR820 design controls
• Hands on risk management
• Experience with design product DFMEA tools
• Hands on design for manufacture tools and techniques
• Experience with aligning product DFMEA to process PFMEA tools
• Hands on CAD/CAE, preferably Creo
• Tolerance stack analysis and statistical tools; JMP preferred
• Materials expertise in medical-grade plastics, springs, and elastomers preferred
• Good understanding of the English language, both written and spoken
• Comfortable working in different cultures
• Flexible with a can-do and hands-on mentality
• Self-starter able to work autonomously
• Excellent problem-solving skills
• Good planning and organization skills
• Six Sigma training desirable
• Track record with patent filing and/or patent management desirable
• Detailed understanding of respiratory standards and regulatory requirements desirable
• Experience with complex respiratory devices desirable

Core Competencies

Demonstrates expertise in medical device design and development, with a strong focus on regulatory compliance, design controls, and risk management. Proficient in CAD/CAE tools, particularly Creo, and experienced in applying analytical methods and statistical tools for product development.

Highest-signal resume keywords

• Master In Mechanical Engineering
• Medical Device Design Expertise
• CAD/CAE Proficiency, Preferably Creo
• DFMEA And PFMEA Alignment
• Hands On Risk Management

Hard Skills

• Design Controls
• Tolerance Stack Analysis
• Statistical Tools
• Analytical Methods
• Proof-Of-Concept Activities
• Design For Manufacture Techniques
• Version Control
• DFMEA Tools
• Empirical Testing
• Documentation Writing

Soft Skills

• Excellent Problem-Solving Skills
• Good Planning And Organization Skills
• Flexible And Hands-On Mentality
• Self-Starter
• Comfortable Working In Different Cultures

Certifications & Qualifications

• Six Sigma Training

Industry Keywords

• Medical Device Standards
• CFR820 Design Controls
• Respiratory Standards
• Patent Filing
• Patent Management

Tools & Technologies

• CAD Software
• PDM Software
• JMP
• 8D Problem-Solving Tools
• Medical-Grade Plastics
• Springs
• Elastomers