Friday, September 27, 2013

Combination Product Device Engineer



Description of Work:

The St. Jude Medical Principal Hardware Design Engineer will be responsible for the design of hardware that will be part of new combination product medical device definitions.

St. Jude Medical Hardware Design Engineer will be involved with Design Verification testing (DVT) protocols

Assignments may include, but are not limited to, collecting product design requirements and may proceed through the full life cycle of steps documenting, designing, testing and releasing products expected to meet high reliability hardware design standards

Capturing, analyzing, implementing, and validating applicable product or hardware design concepts, requirements, and designs

Work requires the application of theoretical principles and creative/analytical techniques

Apply advanced engineering and scientific principles to the evaluation and solution of technical problems

Initiate the planning, organizing, performing, coordinating and/or directing of engineering work

Perform technical studies

Remain abreast of and consults on technical advancements

Identify and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness


Desired skills and qualifications:


10+ years of work experience in hardware design, development, or testing capacity

Combination product knowledge

Drug eluting experience desired

Comprehensive familiarity with manufacturing equipment/processes compatible with highly reliable electronic medical or similar devices

Ability to develop new design features as part of existing systems

Qualified record of implementing new processes to existing hardware design and related systems

Proven ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees

Record of delivering software engineering information which adds value to management decision making process

Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks

Must be able to handle multiple assignments

Expert ability to efficiently use good drafting practices such as The American Society of Mechanical Engineers (ASME) Y14.5

Bachelor of Science Degree in Electrical/Mechanical/Biomedical Engineering, a related field, or equivalent (Advanced credential in a relevant discipline/concentration)

Professional certification or designation

Training and experience in manufacturing processes and methods

Specialized experience and/or relevant advanced coursework related to the hardware applications, programs, and processes


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St. Jude Medical is an Equal Opportunity Employer






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