Philips Sr. Manager, Design Validation in San Diego, California
As Sr. Manager Design Validation your team provides the project teams with a complete package of Evidence ensuring our products meet the intended use & clinical user needs, including clinical, technical and workflow data for substantiation of clinical and performance claims. You will work cross-functionally with key stakeholders and partners from R&D, Regulatory, Marketing and Clinical Science teams. To support definition and substantiation of strong claims to position our solutions in the market and improve the Usability of our products. You will ensure that this data is delivered on-time and the product submissions are first time right.
We welcome you to join Volcano a Philips Company as a Sr. Manager Design Validation in our San Diego, CA location.
Are you a seasoned Leader and would you like to be part of a dynamic team that is the market leader in its field? Do you have a solid experience in cardiac/cardiovascular medical equipment/devices?
Then our opportunity within our Image Guided Therapy Devices (IGT-D) business is the role for you!
You will drive the execution of all the system level usability and validation activities within the IGT-Deices R&D organization.
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.
The Sr. Manager Design Validation is leading for the strategic direction of four key business areas: Design Validation, Usability Engineering, Clinical Evaluations and Instructions for Use. You are leading a high-performance, diverse team of individuals overseeing the Design Validation activities throughout the Life Cycle of our IGT Devices Products.
You are part of the Systems Engineering Leadership Team together with 2 other key departments, responsible for ensuring timeliness and quality of bringing our products to Market.
You are responsible for
Accountable for the departments planning & execution of all Design Validation activities
On-time and to quality for both New Product Introduction Projects and Life Cycle Management teams
Maintenance of Evidence in line with the Defined Post-Market Surveillance and Clinical Follow-up Activities
Responsible for Department Staff
Resource management and allocation to all business activities (projects & improvements)
Talent Management, staffing, performance management, coaching
Motivation of the team, creating and maintaining an inspiring, respectful work environment
Competence Management in fields of Global Regulations (EU, USA, China, etc), and Clinical Applications of our Products
Accountable for the Quality Management Procedures for the areas of business responsibilities (Design Validation, Usability, Clinical Evaluations, Instructions for Use)
Ensure all procedures are in compliance with the current Global Regulations
Deployment & training of all Quality Procedure across the IGT Systems Business
Lead & execute Continuous Improvement of Quality Management Procedures together stakeholders
Responsible for Relationship Management
Building a network within your peers within Philips Health Businesses
Working with external suppliers for customer recruitment, usability, & regulatory consultants
Alignment with greater IGT organization to learn from each other, support peers and drive excellence
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.
You will be part of the Systems Engineering leadership team within the Image Guided Therapy Devices business unit, which is responsible for marketing, development and manufacturing of cardio-vascular systems and devices in medical diagnosis and intervention. Customers are interventional specialists, in the cardiology and radiology domain operating in a wide variety of hospitals across the globe.
You will work closely with cross functional partners (Marketing, R&D, Clinical, Operations, Service and Q&R).
To succeed in this role, you should have the following skills and experience
Proven track record of success in delivering products to the market
Experience with the development of disposable devices (catheters, guide wires, balloons, stents, consoles)
Track record of building strong collaborative relationships with other functions (marketing, development, Operations, Q&R) to ensure work is grounded in reality
Experience in usability, validation and regulatory
Proven skill in working in a clinical environments
Proven skill in working in a regulatory environment
Effective in navigating in a highly matrixed organization; leverages relationships and influences key decision-makers and business leads
Skilled in team development and people leadership
Strong conceptual and strategic thinking
In return, 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.