Senior Mechanical Engineer
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- 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
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