Philips Sr. Medical Device Design Verification Engineer in San Diego, California
We welcome you to join Volcano a Philips Company as a Sr. Medical Device Design Verification Engineer in our San Diego, CA location.
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) at https://intranet.philips.com/Pages/Image-Guided-Therapy.aspx business group. As the Sr. Medical Device Design Verification Engineer, you will support product design activities and development of technology destined for transfer to Costa Rica.
You will be involved in all Design Control phases, especially focused on the design verification and validation of the product, which also includes system level testing. The position will contribute all aspects of the design process, with a focus on verification and validation level testing. This person will be a key point of contact with Systems Engineering and System Verification groups and work on strategies to ensure complete verification testing.
You are responsible for
Knowledge of medical devices in FDA regulated industry
Develop strategies for both product and system level verification testing and requirements. Write advanced technical reports and test plans
Coordinate verification and validation studies and independently writes plans and reports.
Provide needed training on disposable product (catheter and wire) uses, requirements and testing to groups such as Systems Engineering and Systems Verification.
Create, review and optimize test design, reusable test cases and test procedures to ensure complete functional and non-functional test coverage for multiple projects concurrently
Maintain production-like test environment for formal verification and subject to strict change control
Strong contributor to the creation and execution of project plan associated with new products
Oversee the generation of work instructions, preventative maintenance schedules, documentation for components, tooling, and processes of moderate complexity; able to perform operator training
Support generation and maintenance of pressure wire Process FMEA as part of the Design Control process
Lead the transfer of new designs from R&D to production
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
Able to teach design controls and defend in audits (mentors)
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 including, but not limited to verification and validation plans, DOEs, Gage R&Rs
Leads the development and validation of new test methods
Define, perform and analyze complex linear experiments and complex DOE’s
Define verification strategy. Drive and approve formal verification phase
Plan, oversee and execute the verification activities in the project/system, including initiation, test design, coordination, synchronization, review and integration of the technical work
Ensure requirements are scoped to the proper level of detail and are testable
Support and interact with other teams for verification, integration, validation and post validation - problem solve and take feedback into the next improvement cycle which includes includes coordination and collaboration with cross-functional and other verification teams
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
Maintain automation of scenarios in area of domain expertise, ensure test output delivers a reliable report for the purpose of test evidence
Work with development leads to employ iterative development test strategies and tactics on assigned projects and ensure full execution of the strategy
Provide effort estimates
Create, review and optimize test design, reusable test cases and test procedures to ensure complete functional and non-functional test coverage for multiple projects concurrently. Create defects trends analysis to recognize the weaken areas of the design
Analyze available data and identify trends and track actual testing progress against the plan and ultimately provide visibility into release readiness and release quality
Work closely with automation architect to develop functional automation infrastructure and automation framework
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 ME, EE, IE, OE, BME, CE or other relevant field with 8+ years of experience in the design, development and manufacturing of a product (device, part, component, etc.), preferably in the medical device industry
Pressure Guide Wire and IVUS catheter or equivalent disposable medical device experience, especially skilled in design control process and deliverables
Must be able to read/write and speak English
Strong technical writing skills for generation of specifications, build method, work instructions, technical protocols and reports
Strong communication skills both written and verbal to provide updates and feedback to management and team members
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Use data to drive decisions
Product transfer experience with strong understanding of product transfers from R&D to high volume manufacturing
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
Proficient with additional software packages as required such as statistics software.
Strong analytical and problem solving skills
Demonstrate organizational and interpersonal skills working in a cross-functional, regulated environment
Knowledge of testing methods at all levels (unit, integration, system, V&V, acceptance) applied within the development lifecycle
Test automation experience is a plus
Provide guidance and training to production operators
Pressure Guide Wire, Catheter or related technology experience
Solidworks/ CAD (Drawings understanding)
Requirement and test management tools (such as Doors, HPALM)
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video
Find out more info about Philips at www.philips.com/na/careers
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.