Hardware System Test Engineer 3 - Disposable Verfication

Spectranetics   •  

San Diego, CA

5 - 7 years

Posted 261 days ago

This job is no longer available.

In this role, you have the opportunity to work with a cutting edge product line - IGT Devices is part of the Philips Image Guided Therapy (IGT) business group.  As the Hardware Systems Test Engineer – Disposable Verification, you will make a substantial contribution to the innovation of product and process. You will develop new products, using the latest technologies and resources, often realizing systems based on unverified specifications.

You are responsible for

  • System verification with focus on disposable product (catheter and wire)
  • Create test strategies for both system level and disposable product level verification testing
  • Lead the System & Disposable requirement review effort to ensure that requirements are actionable, measurable and testable
  • Create test plans, test cases and test reports independently with very little supervision
  • Implement and monitor structured system verification (manual and automated) strategies/methodologies
  • Create, review and optimize test design, reusable test cases and test procedures to ensure complete functional and non-functional test coverage
  • Maintain production-like test environment for formal verification and subject to strict change control
  • Provides needed training on disposable product (catheter and wire) uses, requirements and testing
  • Create clinical relevant end to end user scenarios
  • During the product development process, evaluates new product/process technology (internal or external), fixture design, tooling, equipment features/changes, and test methods.  Mentors technicians, engineers and junior members of the team
  • Define and measure key progress indicators on requirement coverage, test case effectiveness, Test execution and defect identification and closure
  • Supports generation and maintenance of disposable Process FMEA as part of the Design Control process
  • Strong knowledge and experience with Regulatory requirements associated with design controls
  • Develops and/or guide others in statistical analysis and problem solving.  Development of statistical rationale plans for development studies techniques
  • Leads the development and validation of new test methods
  • Review and approve executed test results to confirm test results provide proper objective evidence requirements are met and are compliant to the verification process
  • Coordinate verification activities over multiple teams or global locations

You are a part of

Our solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology. 

To succeed in this role, you should have the following skills and experience

  • Requires Bachelor’s degree in EE, ME, BME, CE or other relevant field with 5+ years of experience disposable testing, preferably in the FDA regulated medical device industry
  • Pressure Guide Wire and IVUS catheter or equivalent disposable medical device experience, especially skilled in design verification
  • Strong technical writing skills for generation of specifications, build method, work instructions, technical protocols and reports
  • Strong communication skills both written and verbal
  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
  • Use data to drive decisions
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
  • Proficient with Microsoft Office products (Outlook, Excel, PowerPoint, Word, Visio, Project) to create schedules, presentations, graphs and charts and doing analysis
  • Demonstrates strong organizational and interpersonal skills working in a cross-functional, regulated environment
  • Strong analytical and problem solving skills. Proficient with additional software packages as required such as statistics software
  • Knowledge of testing methods at all levels (unit, integration, system, V&V, acceptance) applied within the development lifecycle
  • Self-motivated and a team player
  • Pressure Guide Wire, Catheter or related technologyexperienceis a plus
  • Solidworks/ CAD  (Drawings understanding)
  • Requirement and test management tools (such as Doors, HPALM)

In return, we offer you

We offer you the opportunity to grow within the organization and Philips – working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people’s lives every day.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video