Senior Design Assurance Engineer

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).

• 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 and 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 a strong understanding of all aspects of the QMS related to Design/Process Controls.
• You have a strong understanding of Medical Device QSR regulations/standards including ISO 13485, ISO 14971, 21
  
  CFR (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).
• You must be able to successfully perform the following minimum physical, cognitive and environmental job requirements with or without accommodation for this position
  .

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 the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role.

• 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.

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, 401(k) (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Benefits details can be found.

• This role may require travel up to 10%.
• US work authorization is a precondition of employment. The company 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 within commuting distance to Plymouth, MN.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.