Sr. Mechanical Engineer

Pleasanton  ‐ Onsite
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Keywords

Description

Summary:Develops medical products from concept through production

Essential Duties and Responsibilities include the following (other duties may be assigned.):

* Completes layout and design of electronics packaging and fluidic system layout and packaging for a medical device.
* Conceive, design, build, and evaluate prototypes to explore a range of design concepts. Refine and develop selected concepts.
* Prepare, present, and document designs at reviews.
* Investigate and evaluate materials, adhesives, and assembly techniques.
* Manage vendors, request quotes, and prepare purchase orders.
* Perform pressure and flow analysis for fluidics systems.
* Plan, perform, and document verification testing.
* Interact with Clinical and Marketing departments to determine design requirements and goals.
* Design and validate packaging to ensure safe handling and transportation of devices.
* Document assembly procedures, and coordinate design transfer to manufacturing.
* Document ECO changes within Document Control process.

Other Duties and Responsibilities:

Products under development are likely to include:
* Injection molded plastic parts.
* Sheet metal enclosures including EMI mitigation.
* Large plastic enclosure panels and structural bases.
* Electrical connectors and cabling.
* Selection of pressure, flow, force, and temperature sensors
* Elastomeric components

Qualifications:

* BS in Mechanical Engineering or equivalent degree.
* At least five years of product design and development experience required, ten years preferred.
* Prefer at least five years of experience in medical devices, ideally class II devices.
* Must be proficient with Pro/E Wildfire/Creo.
* Candidate should be a strong team player with the demonstrated abilities and willingness to wear "multiple hats" and perform a wide range of tasks.
* Individual must have strong verbal and written communication skills
* Must be familiar with the capabilities and limitations of a variety of fabrication techniques (e.g. plastic injection molding, vacuum and pressure forming, sheet metal, stamping, machining).

Additional Requirements:

* Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements.

To find out more about Real please visit www.realstaffing.com
Start date
08/2013
From
Real Staffing
Published at
09.08.2013
Project ID:
580156
Contract type
Permanent
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