Responsibilities:

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.