R&D Engineer - 6 month contract to hire opportunity. Strong likelihood of conversion.

SUMMARY:

R&D Engineer needed to provide support for medical device design and development activities for a thriving medical device organization.

DUTIES & RESPONSIBILITIES:

* Provide input and support for product concept and design, development, prototyping, manufacturing and testing

* Sourcing and oversight for suppliers, materials and components, including supporting development of specifications, purchasing, quality inspection and resolution

* Verification and Validation and relevant data collection, analysis, reporting and documentation

* Regulatory, Quality Systems, and ISO Compliance (60601)

* Other duties, as required

QUALIFICATIONS & REQUIREMENTS:

* 3+ years of relevant experience in medical device (catheter-based preferred) research and development, including a good understanding of related regulatory, Quality Systems and ISO compliance

* Proven technical writing experience (component specs, Manufacturing Process Instructions, protocols, reports, etc.)

* Proven software proficiency in MS Office and SolidWorks, and statistical analysis using Minitab and/or MS Excel

* Good understanding of Design Control processes and compliance and Risk Management

* Experience with V&V and related data collection, analysis, documentation and reporting

* Relevant BS Degree

LOCATION:

Work will be performed onsite in the greater San Francisco Bay Area.