Senior Design Assurance Engineer

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, component qualification, statistical analysis of data, design verification and process validation planning as well as quality system compliance.

• Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements.

• Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will ensure specific quality levels.

• Works with cross functional teams to complete component 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.

• 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). ASQ certifications (desired).

• 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 and compensation decisions are dependent upon the facts and circumstances of each case.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .

We are a health technology company. We built our entire company around the belief that every human matters, and we won’t stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.