Lead Mechanical Engineer

Responsibilities

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 architerctures
• 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

We are looking for

The successful candidate will possess the following knowledge, skills education and experience:

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, machinings 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