Senior Design Quality Engineer

Philips•Cambridge, MA

2d•$103,000 - $143,000•Onsite

About The Position

In this role you will be part of a team that is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience in challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality-of-life billions for the billions of people Philips brand touches each year. Your role: Accountable for oversight of system and hardware quality and safety risk management throughout the product life cycle. A Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone. Performs independent technical assessment on product quality performance and post-market product quality analysis.

Requirements

Bachelor's / Master's Degree in Engineering or Science or equivalent.
5+ years of experience, 2+ years of experience in product design as demonstrated by a role in quality, engineering, service, or manufacturing in a regulated environment with Medical Device experience.
Experience with FMEAs and Product Safety Risk Management.

Nice To Haves

Expertise in Application of Risk Management to Medical Devices (IEC 14971), Medical Device Software Life Cycle Processes (IEC 62304), and Application of Usability Engineering to Medical Devices (IEC 62366), 21CFR820 are pluses.

Responsibilities

Accountable for oversight of system and hardware quality and safety risk management throughout the product life cycle.
Provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone.
Performs independent technical assessment on product quality performance and post-market product quality analysis.