Lead Mechanical Engineer
2 weeks ago
The Lead Mechanical Engineer will be a member of the Product Development staff and be involved in the design, development, and maintenance of new MRI compatible products.
- Responsible for the mechanical design of future generations of MR Patient Care products
- Coordinates and mentor junior engineers in research, design, development, and implementation of product architectures
- Connect and align with project management on project content, timeline and costs
- Responsible for requirements, design, implementation, test and integration of module/sub-system in accordance with the higher level requirements and specifications
- Conduct concept & feasibility studies. Lead the introduction of new technologies
- Act as mechanical lead to review and provide oversight of R&D activities (i.e. internal and external support) developing products for the MRI.
- Oversee compliance and V&V activities, including offsite test management.
- Lead design reviews, FMEA analyses, and other DfX related activities.
- Review and ensure adequacy of supplier qualification activities.
- Analyze technical issues using methodical problem solving techniques and provide root cause / solutions where required.
- Actively participate on cross-functional/cross-business project teams through all phases of product development to ensure successful execution of innovative, best-in-class designs.
- Network with colleagues within BU and beyond and maintain external contacts for benchmarking, new technologies, tooling, design methods, and reflects them to the HW-group
- Draws up personal schedule and reports on progress
Essential Requirements:
- Bachelor of Science degree required, (Masters of Science preferred) with a concentration in an engineering discipline.
- At least 10 years of engineering design experience.
- Experienced in designing mobile and portable electronic enclosures.
- Familiarity with Current ISO standards family that apply to medical devices.
- Ability to interface with internal stakeholders and be effective at managing suppliers.
- Experienced in design of die castings, injection moldings, machining and sheet metal.
- Experience in using Finite Element Analysis (FEA) programs to analyze designs for static and dynamic stresses.
- Experience in using 3D Parametric tools (Creo, Solidworks, etc.).
- Knowledgeable of ASME Y14.100 Engineering Practices.
- Proficient in Geometric, Design and Tolerancing (GD&T) principles.
- Experience with design reviews based on failure modes (DFMEA)
- Experience with design of experiments (DOE)
- Experience with requirements deconstruction from subassemblies to components.
- Experienced in rapid prototyping techniques (CNC Machining, 3D Printing, Sheet Metal, etc.)
- Ability to understand and debug problems across hardware / software / system boundaries
Desirable:
- Class 2 or Class 3 medical device development experience.
- Understanding of global regulatory requirements for medical devices.
- LEAN/Six Sigma certification or experience.
- Familiarity with risk management through a full product development cycle from requirements to validation.
- Experience with DOORS requirement management tool and Creo 3.0.
- Experience in the field of Medical Devices product design e.g. CT, MR, X-Ray, Mammography systems etc. will be an added advantage
- Exposure to International Medical Quality and Regulatory Standards e.g. IEC, FDA, UL, CE is a plus
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