Philips Sr. Design Controls Manager - Systems Engineering in Andover, Massachusetts
System Risk Management and Requirement Engineering
uFMEA/dFMEA/pFMEA, DoE, Design Verification, Engineering Analyses, CTQ/CTS
Understanding of Embedded systems SW, HW platform independent application SW
In depth knowledge of risk management processes in compliance with ISO 13485, EN/ISO 14971, and IEC 60601 standards, and global regulations (i.e. FDA, EU, CFDA, etc.)
In this role, you have the opportunity to
The Senior Design Controls Manager is a key and critical role within the Risk Management Group within Philips Monitoring Analytics & Therapeutic Care (MA&TC). This is an opportunity to take a leadership role in a well-seasoned winning team that owns the risk management process and supports its effective deployment for all MA&TC medical devices / products. The risk management team plays a very important role in ensuring products designed by Philips are of the highest quality and meet all applicable international standards.
You are responsible for
Technical leadership and acceptability of the application of the Philips Risk Management Process. The scope includes ownership of the risk management process and procedures, identify need and support training activities for the effective application of the risk management process, lead risk management activities and act as technical liaison to the risk management process, support BUs in requirement management and design specification activities, identify and facilitate the process interfaces, enable design reviews and coordinate risk management file reviews.
Define and shape the End2End Risk Management processes
Lead and support the safety and quality vision embedded in the risk management process to Philips BUs and team members.
Lead and coordinate efforts to establish product safety and reliability goals and to plan, execute and monitor activities aimed at achieving those goals.
Provide technical depth of knowledge in system engineering tools and methodologies like uFMEA/dFMEA/pFMEA, DoE, Design Verification, Engineering Analyses, CTQ/CTS flow down.
Support site wide training on risk management and product reliability/quality best practices.
Provide support for the application of the risk management process to all Philips BUs, identifying the interfaces between the functional areas involved in the creation and sustainability of medical devices that are safe and effective.
Lead the definition, documentation, implementation and improvement of risk management policies, processes and practices.
Act as technical liaison to cross functional teams in the implementation of the risk management process.
Support the BUs in translating safety/reliability/quality requirements into Design Control measures by means of the use of system engineering methodologies.
Review BUs risk management files to ensure that they comply with the requirements of the risk management process (and applicable standards).
Support investigation activities for the determination of root causes of product and performance deviations (e.g. CAPAs and HHEs).
Ensure compliance with the design control process and with the Philips Quality Management System.
Provide technical support and foster a culture of effective Risk Management practices.
You are a part of
The Senior Design Controls Manager position will be part of the Philips Andover Quality Transformation group and report to the E2E Project Manager (Risk Management), Systems Engineering Manager. The position will focus on E2E Supplier Control system and process engineering activities.
To succeed in this role, you should have the following skills and experience
BSEE /MSEE with 12+ year experience in the design and development of medical devices combining multidisciplinary engineering fields and technologies (i.e. electric/electronic, mechanic, computer, connectivity, system engineering, etc.).
Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international, namely the IEC/ISO 60601-1 family of standards, including collateral and particular (part 2) application standards.
Application knowledge of design controls and risk management processes in compliance with ISO 13485 and EN/ISO 14971 standards and global regulations (i.e. FDA, EU, CFDA, etc.).
Experience with FMEA, APQP is highly desirable
Demonstrate ability to lead, communicate, interact and influence effectively at technical levels across functions.
Demonstrate competence in the use of system engineering tools and methodologies.
Highly passionate and positive infectious attitude who strives for high performance and product safety and quality.
Ability to effectively implement continual improvement to increase effectiveness of the risk management process.
Proficient in standard office computer tools: Microsoft Office, Word, Excel, Project and PowerPoint.
Excellent English skills, written and speaking.
In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
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 .
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.