Senior Test Engineer
Description:
This position reports to the Vice President of Research and Development and is responsible for managing the development, validation, and maintenance of automated and manual test processes and equipment that support Production and Product Development.
Duties and Responsibilities:
- Manages all aspects of production test development including schedule, test plan, test specification, test procedure, software development, fixture and tool development, verification and validation execution, and test implementation.
- Establishes and maintains production test development roadmap.
- Manages the definition, development, and implementation of Catheter tests at suppliers.
- Works within a cross-functional development team on the definition of new medical products.
- Works with Product Development to optimize test solutions and manufacturability of catheters and systems products.
- Works with Product Development to ensure the manufacturability and testability of catheters and systems during development.
- Develops and maintains test specifications, test requirement documents, plans/protocols/reports for test verification and validation, and production test procedures.
- Develops, documents, validates and maintains test fixtures and test systems for Production.
- Coordinates supplier requirements for testing with Product Development.
- Performs data trending analysis and participates in root-cause failure analysis.
- Supports the Quality System in regards to Production and Process Controls. Develops Standard Operating Procedures (SOPs), implements and trains others for product specific Work Instructions (WIs), and creates in-process control systems.
- May involve up to 25% travel time to work with contract manufacturers.
- Other duties as required by a growing, changing high tech company.
Desired Experience:
- Bachelor’s degree (BSME preferred) in a related engineering discipline is required.
- 8+ years working in a medical device company as an engineer also required. With experience in a catheter manufacturing environment preferred.
- Experience with production and test fixture design essential.
- Experience with mechanical CAD software (SolidWorks, ProEngineer) a plus.
- Experience with new product development and product realization optimal.
- Strong oral and written communication skills required as well as excellent task and time management skills.
- Superb organizational skills with excellent attention to detail and sophisticated analytical skills a must.
- Must demonstrate a strong work ethic, dependability, consistency, drive and passion to ensure our Company’s success.
- Start up or small company experience ideal.
Please send your cover letter and resume to opportunities@coaptus.com.
CoAptus Medical Corporation is and Equal Opportunity Employer
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