Sr Manager, Design Quality Engineering
- Carlsbad, CA
Sr Manager, Design Quality Engineering
In this role, you have the opportunity to
Be a key leader in the Quality organization as the Senior Manager of our Design Quality team within the Hospital Respiratory Care organization. In this role you will directly lead a diverse team of Design Quality Engineers, Software Quality Engineers and Design Quality Analysts to ensure effective support for New Product Introduction (NPI), Sustaining projects, Compliance and Quality system initiatives. Your skills and knowledge will enable implementation of advanced quality engineering tools and methods to develop and deliver safe and effective medical device products that save lives and improve health. As Manager of Design Assurance Quality Engineering, you will also work within the Quality Management System (QMS) to support the design controls process during development of new medical devices. You will apply company policy and procedures to work with supporting team members to analyze situations or data and draw conclusions in support of CAPA(s). Assignments will include creating, reviewing and updating documents, review of product requirements, auditing Design History Files and supporting direct reports who act as core team leads on new product development projects.
You are responsible for
- Manage and Lead the design quality engineering support for NPI projects to ensure all quality objectives are met and products are developed in accordance with design control regulations
- Manage and lead engineers for investigation of field problems associated with product design
- Manage and lead software quality engineering support for product and non-product software applications
- Develop engineering team through coaching, mentoring and performance management to deliver a world class functional team.
- Support Risk Management processes throughout the product lifecycle from initial development through post market surveillance in accordance with Philips processes and global standards (ISO 14971).
- Develop and maintain quality system processes relevant to the department in accordance with Philips global quality system requirements and applicable US and international regulations
- Support post market surveillance processes through the analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.
- Develop mastery of our products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles
- Participate as key Quality Leader in organizational activities such as Product Design Reviews, Phase Gate Reviews, Quality Review Board, CAPA Review Board, and other related activities.
- Understand and implement processes and intent of all aspects of the QMS related to Design Controls
- Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement project
- Drive engagement within and develop Design Assurance team members
- Ensure that NPI projects are adequately staffed and supported
- Using engineering principles, analyze situations or data to identify gaps between project work and QMS
- Work with teams and other Design Assurance team members to ensure compliance to the QMS
- Develop and implement new and improved quality/compliant pre-market engineering methods, techniques and processes.
You are a part of
The Philips Hospital Respiratory Care business products include invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment. We believe that by understanding our customers' problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.
To succeed in this role, you should have the following skills and experience
- BS in Engineering, Sciences, or a related field. MS preferred.
- 8+ years' experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry. 5+ years' experience with a MS or higher.
- 5+ years' experience leading and managing people.
- Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards.
- Strong understanding of design quality tools, methods and activities
- Strong statistical background preferred in reliability / verification, hypothesis testing, sampling, multi-factor analyses
- Demonstrated expertise in managing complex projects and implementing cultural change.
- Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.
- Green Belt or Black Belt certification preferred.
- Excellent team work skills including influencing and building rapport with internal customers and stakeholders.
In return, we offer you
The opportunity to be part of an organization that is committed to touching 3 billion lives worldwide. The opportunity to use your data analytic skills to support products that provide lifesaving diagnostics and therapy. A chance to grow your professional skills in an environment that values diverse ideas and creative approaches.
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 . 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 on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
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