Philips Production Controls Manager - Systems Engineering in Andover, Massachusetts

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The Production 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 become part of 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

  • Contributor to the risk management process and procedures;

  • Identifying needs and support training activities for the effective application of the risk management process;

  • Supporting risk management activities and acting as a technical liaison to the risk management process;

  • Supporting business units in requirement management and design specification activities;

  • Identifying and facilitating the process interfaces; and,

  • Enabling design reviews and coordinating risk management file reviews.

  • Supporting the safety and quality vision embedded in the risk management process to Philips BUs and team members.

  • 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.

  • 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 Production Control measures by means of the use of system engineering methodologies.

  • Provide technical depth of knowledge in system engineering tools and methodologies like dFMEA/pFMEA, DfX (DfM, DfA, DfS, DfT, DfV), APQP, IQ/OQ/PQ, Control Plan, SPC, Measurement System Analysis, CTQ/CTS

  • Support site wide training on risk management and product reliability/quality best practices.

  • Lead and drive continuous improvement of Manufacture Testing and Processes (Risk-based testing)

  • Lead and coach Design Transfer into production process using risk-driven approach

  • Lead and drive in planning and execution of production control risk management activities

  • Provide technical support and foster a culture of effective Risk Management practices

  • Provide technical depth of knowledge in Risk Management standards and processes, as well as production controls in supporting of the implementation of End2End Risk management activities.

You are a part of

The Production 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 (or equivalent engineering degrees) with minimum of 15 years of experience in new product introduction (NPI) of complex products, preferably in the medical industry

  • Demonstrate the ability to lead, communicate, interact and influence effectively at all levels across functions and business units

  • Demonstrate the knowledge of all manufacturing phases from process specification creation thru post release process monitoring

  • Demonstrate the knowledge of production tools such as SAP, eDMR, CAPA, etc

  • Demonstrate the ability to lead projects including process changes in production environment

  • 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 and IQ/OQ/PQ 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.

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 . 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 on our career website, where you can read stories from our employee blog at . Once there, you can also learn about our recruitment process at , or find answers to some of the frequently asked questions at .

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.