Senior Design Assurance Engineer

Koninklijke Philips N.V•Plymouth, MA

61d•$91,350 - $146,160•Onsite

About The Position

The Senior Design Assurance Engineer will play a critical role in support of the design controls process, with a focus on Sustaining and New product development (NPI) of Philips' Image Guided Therapy Devices (IGTD). Your role: Ensures Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, and updating risk documents,ponent qualification, statistical analysis of data, design verification and process validation planning as well as quality systempliance. Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements. Determines and rmends sampling plans, equipment requirements, measurement techniques and training requirements that will ensure specific quality levels. Works with cross functional teams topleteponent qualification activities, plan/conduct design verification (DVT) and process validation activities. Participates in the development/results analysis of verification and validation (V&V) plans and test protocols to qualify and validate new product designs and processes. How we work together: We believe that we are better together than we are apart. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in thepany's facilities. Field roles are most effectively done outside of thepany's main facilities, generally at the customers' or suppliers' locations. This is an Office role. About Philips: We are a health technologypany. We built our entirepany around the belief that every human matters, and we won't stop until everybody everyw has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details: The pay range for this position in Plymouth, MN is $91,350 to $146,160. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role andpensation decisions are dependent upon the facts and circumstances of each case. In addition, otherpensation, such as an annual incentive bonus, salesmission or long-term incentives may be offered. Employees are eligible to participate in ourprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (withpany contribution), stock purchase plan, education reimbursement and . Details about our benefits can be found . Additional Information: This role may require travel up to 10%. US work authorization is a precondition of employment. Thepany will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or withinmuting distance to Plymouth, MN. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to as soon as possible to ensure consideration. Philips is an

Requirements

You have a minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971) and strong Understanding of all aspects of the QMS related to Design/Process Controls.
You have strong understanding of Medical Device QSR regulations/standards including ISO 13485, ISO 14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR.
You're able to analyze quality data and draw conclusions regarding trending, KPI's etc.
You have extensive experience supporting the creation and review of all medical device documentation including- Component qualification, Design Verification Test/regression plans, test protocols/reports, process validation, issue tracking/resolution and auditing Design History Files (DHF).
You have the proven ability to cultivate and maintain strong relationships with team members and internal/external stakeholders.
You have a minimum of a bachelor's degree in Quality, Engineering (Mechanical, Chemical, Biomedical) or a related Scientific discipline (required).
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this position.
US work authorization is a precondition of employment.
For this position, you must reside in or withinmuting distance to Plymouth, MN.

Nice To Haves

ASQ certifications (desired).

Responsibilities

Ensures Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, and updating risk documents,ponent qualification, statistical analysis of data, design verification and process validation planning as well as quality systempliance.
Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements.
Determines and rmends sampling plans, equipment requirements, measurement techniques and training requirements that will ensure specific quality levels.
Works with cross functional teams topleteponent qualification activities, plan/conduct design verification (DVT) and process validation activities.
Participates in the development/results analysis of verification and validation (V&V) plans and test protocols to qualify and validate new product designs and processes.