Design Assurance Engineer

Updated Jd

Requisition has been edited [Requisition ID: PHHJP00022118, Requisition Title: QA Engineer Consultant II]

Description

Job Title for this role is Design Assurance Engineer

Max Bill Rate is $100.00 including MSP fee. Anyone submitted over this rate will be rejected.

Local Candidates required as this will be a hybrid schedule of 3 days onsite and 2 remote.

Notes from the manager: Medical Device experience is required. This person will be reviewing items thru Solidworks so they need to have experience and be comfortable reviewing these details. This person will be assisting in simplifying part number changes by creating a smart sheet that allows these changes to be made easier. Windchill experience is highly desired. Bachelors Degree is required.

The Design Assurance Engineer will support design controls and quality management associated

with the development, transfer and sustaining initiatives for the Peripheral Vascular business of

Philips Image Guided Therapy Devices. Products include Class III non-implantable and implantable

medical devices including drug combination devices.

You will have the opportunity to work in a team environment to efficiently maintain quality standards

and meet our customer demands.

You are responsible for

• Lead all quality elements of Design Controls and product DHF for design projects.
• Drive Quality norms associated with design engineering projects.
• Support integration of Risk Management processes throughout the product lifecycle from initial
  
  

development through post market surveillance in accordance with Philips processes and global

standards.

• Lead Quality Plan initiatives associated with Risk Management and Quality System integration.
• Support integration of post market surveillance processes into Design Controls and Sustaining
  
  

initiatives through analysis of field performance, identification of trends and risks, and actions

to eliminate or mitigate adverse post market issues.

• Support the Regulatory Affairs department for submissions and respond to submission
  
  

questions.

• Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement
  
  

initiatives.

• Analyze situations/data using engineering principles and collaboration to identify gaps between
  
  

project work and QMS.

• Quality responsibility for transfer of new products and sustaining projects to manufacturing and
  
  

operations quality and supplier quality teams.

• Support internal and external audits.
• Acts in full compliance to all applicable regulatory requirements and Philips Quality policies.
  
  

BS in Engineering, Sciences, or a related field.

• 4+ years' experience in Quality Assurance, Design Engineering, Systems Engineering, or similar
  
  

in a regulated industry

• 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 in verification, validation, hypothesis testing, sampling, multifactor analyses and measurement system analysis.
• Demonstrated expertise in managing complex projects.
• Excellent customer service and interpersonal communication skills, experience leading
  
  

presentations in front of peers and managers.

• Hands-on problem solver that drives solutions within teams.
• Excellent teamwork skills including influencing and building rapport with internal customers and
  
  

stakeholders.

• Demonstrated track record of completing projects on-time that meet all objectives.