In this role, you have the opportunity to work with an innovative product line - IGT Devices is part of the Philips Image Guided Therapy (IGT) at https://intranet.philips.com/Pages/Image-Guided-Therapy.aspx business cluster.
As the Sr. Manager, System Design & Validation, you will manage the R&D and implementation processes of system design and validation. You will be responsible for coordinating departmental and cross-functional efforts to deliver new or upgrade existing products. Primary development responsibilities include planning and directing departmental development efforts. The Sr. Manager, System Design & Validation supervises, hires and fires, selects, develops, coaches and evaluates personnel to ensure best practices of system design and human factors engineering are in place. You will assess emerging technologies and may determine how to map them into product development roadmaps. You will need to keep abreast of technical developments through literature, technical contacts, and industry competition. As an R&D manager, you will ensure compliance with product lifecycle and development procedures and processes as well as all applicable quality and regulatory requirements
You will coach, mentor, and develop system design engineers in the use of tools and methodologies to decompose user needs into system, subsystem, and component requirements. You will coach, mentor, and develop human factors engineers in the use of tools and methodologies to needed to develop user needs, conduct usability studies, and develop usability files. The successful candidate will be an accomplished technical expert capable of leading engineering activities to meet user needs, business objectives, and regulatory/safety standards (e.g. cost, size, reliability, maintainability, power, upgradability). As the ideal candidate, you must be a self-starter with broad system design expertise, experience managing and developing high performing teams, and a record of accomplishment of consistently delivering high quality medical devices to the market.
You are responsible for
Developing the department’s objectives, policies, processes and budgets on short and long term, makes sure that the organization can meet the objectives and ensures that the roles and responsibilities are put in place.
Managing the capabilities of the department; to develop and maintain a long-term view on the required competences and knowledge to introduce new technology.
Attracting, retaining, and developing teammates to ensure the best talent is on the team.
Effectively executing performance management to continually improve the talent base.
Creating and maintaining a positive and engaging culture within the R&D function, and ensuring strong cross-functional collaborating with other functions within NPI.
Delivering new products to the market on time, cost, and quality.
Achieving operational plans, guiding Project Managers/Leaders and ensuring the optimal allocation of personnel to the projects and effective project management.
Defining policy with respect to department tools and development environment.
Ensuring department compliance with design controls and Philips Product Development Lifecycle and Maintenance procedures.
Ensuring all employees adhere to all applicable cGMPs, ISO, FDA, corporate, division and local procedures.
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. The role will include interacting with the IGT Systems organization in Best, NL.
To succeed in this role, you should have the following skills and experience
BS Engineering degree, advanced degree preferred
A minimum of 8 years of experience in expanding engineering leadership roles (R&D, Product Development, Program Management, etc.) in a highly regulated industry (medical device preferred).
A minimum of 3 years’ experience managing and leading a team of technical domain, preferably systems engineering.
Successful record of accomplishment leading people, executing complex new product development projects / programs / improvement opportunities (timelines, quality, capacity, capability, cost, productivity, etc.).
Strong leadership skills (change management, communications, building rapport and executing within a complex matrixed global organization)
Effectively communicates to numerous stakeholders including senior management, other Business Groups, internal and/or external customers and staff.
Experience in the use of system engineering tools such as use scenarios, context/interface diagrams, functional modeling, FMEAs, and QFD.
Experience in planning, executing and reporting usability studies.
Familiarity with Medical Development regulations as in FDA 21 CFR part 820, ISO 13485, ISO 14791, The Medical Device Directive, Safety as in EN60601-1 and EMC as in EN60601-1-2 and subordinate regulations highly desirable.
Experience with DfR (Design for Reliability) tools.
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.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
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