Principal Mechanical Design Engineer
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Key skills for this role
About the Role
Akura Medical is seeking a Principal Mechanical Design Engineer to lead the design and development of mechanical components for a blood clot removal system.
Key Skills for This Role
Responsibilities
- Lead design and development of plastic/composite and metallic parts from concept to high volume manufacturing; drive DFM/DFS, manufacturing and tooling decisions with suppliers
- Drive the full mechanical lifecycle: requirements, concepts, prototyping, detailed design, V&V, and transition to production
- Integrate mechanical designs with electronics, firmware, fluid, and user interface elements in collaboration with cross functional teams
- Guide analysis (tolerance stacks, FEA, material selection, root cause) on critical subsystems
- Create creative solutions and product designs to satisfy unmet clinical needs in thrombectomy
- Be a primary contributor to the intellectual property position of the company via invention disclosures and prototypes
- Interact with physicians to assist with product demonstrations and product testing
- Effectively document work throughout the development process through design reviews, manufacturing instructions, test methods, and test reports
- Select and manage suppliers, including understanding of capabilities, materials, and fabrication processes
- Support regulatory filings including writing technical sections and providing general technical input
Requirements
- Bachelor's Degree or higher in Mechanical/Biomedical Engineering
- At least 15 years of experience in complex product development, including regulated products
- Advanced SolidWorks proficiency
- Demonstrated track record as a lead/principal engineer or product design of medical devices from concept through launch
- Strong expertise in injection molding and RIM molding (part design, materials, DFM, cosmetic and structural considerations)
- Strong experience with medical devices under FDA/ISO 13485 or equivalent regulatory frameworks
- Previous experience working with clinical testing, trials, data collection, and statistical analysis
Full Job Posting
Description
- This position represents an exciting opportunity to join the Akura team at an early stage where you will creatively design and develop components, both consumable and capital equipment, of a blood clot removal system.
- The role focuses on mechanical design of various components and assemblies for catheter systems, a console, and cross functional leadership from concept through high volume manufacturing.
- You will be responsible for the design, vendor relationships and testing per applicable standards.
- This is a full time, on site position at our Doha, Qatar office.
Responsibilities, Skills & Hands On Experience
- Lead design and development of plastic/composite and metallic parts from concept to high volume manufacturing; drive DFM/DFS, manufacturing and tooling decisions with suppliers.
- Drive the full mechanical lifecycle: requirements, concepts, prototyping, detailed design, V&V, and transition to production.
- Integrate mechanical designs with electronics, firmware, fluid, and user interface elements in collaboration with cross functional teams.
- Guide analysis (tolerance stacks, FEA, material selection, root cause) on critical subsystems.
- Creative solutions and product designs to satisfy unmet clinical needs in thrombectomy.
- Be a primary contributor to the intellectual property position of the company via invention disclosures and prototypes to demonstrate reduction to practice.
- Interact with physicians to assist with product demonstrations and product testing.
- Effectively document work throughout the development process though design reviews, manufacturing instructions, test methods, and test reports.
- Expertise in design and development of medical devices.
- Expertise in electromechanical and mechanism design of durable medical devices.
- Substantial experience in design of higher volume disposable components.
- Substantial experience in design for molding and machining.
Education & Work Experience
- Bachelor's Degree or higher in Mechanical/Biomedical Engineering.
- At least 15 years of experience in complex product development, including regulated products.
- Advanced SolidWorks proficiency.
- Demonstrated track record as a lead/principal engineer or product design of medical devices from concept through launch.
- Strong expertise in injection molding and RIM molding (part design, materials, DFM, cosmetic and structural considerations).
- Strong experience with medical devices under FDA/ISO 13485 or equivalent regulatory frameworks.
- Previous experience working with clinical testing, trials, data collection, and statistical analysis.
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