Job Description
- Responsible for the mechanical design of future generations of MR Patient Care products.
- Coordinates with 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.
- Active participate on cross-functional/cross-business project teams through all phases of product development to ensure successful execution of innovative, best-in-class designs.
- Maintain internal and external contacts for benchmarking, new technologies, tooling, design methods, and reflects them to the HW-group.
- Draws up personal schedule and reports on progress.
- The successful candidate will possess the following knowledge, skills education and experience:
Requirements:
- Bachelor of Science degree required, (Master 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, machine 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.
- 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.