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Sr. Device Quality Engineer (Medical Device)

The Fountain Group Chicago, IL

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

My name is Josh Stock and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Sr. Device Quality Engineer for a prominent fortune 500 client of ours.  This position is located 100% Remote. Details for the positions are as follows:

 

Job Description            

  • Sr Device Quality Engineer II provides Quality guidance and oversight for the design control and risk management activities with development teams and medical device supplier/testing partners for the development of software devices- supporting all phases of in-house and/or outsourced design and development as well as product support processes including the development of the integrated hardware development for such devices.
  • Represents the Quality function as the designee on the cross-functional development teams comprised of primarily technical device development, device regulatory, IT R&D, and/or digital device development

 

Principal Accountabilities

  • What are the major responsibilities of this job? List the “what”, “how” and “why” of each responsibility and provide examples, as necessary.
  • Use specific verbs of action, such as “researches”, “manages”, “develops”, analyzes”, avoid the phrase “responsible for…”. Indicate % of time spent on each.
  • Accountability Description Percent of Time Spent
  • Supports the QA interface with medical device supplier, internal development team and testing partners to ensure the quality systems are in a state of compliance by: performing the review and approval of quality design issues (e.g., investigations, impact assessments, deviations), and technical development activities (e.g. design changes, verifcation & validation) that impact design control and risk management; providing quality input in supplier assessments and selection; participating in supplier audits as an SME; prepare and maintain device development quality agreements.
  • Ensures documentation content for Design and Development of products.
  • Perform Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. For SaMD and SiMD products.
  • Ensure documentation adheres to internal policies and procedures and applicable regulations and standards. Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization.
  • Support Asset Team and regulatory strategy for filing; implementing changes through authoring and/or reviewing sections of filing applicable to design control, risk management and specification and supporting responses to regulatory questions, and/or leading the Quality subteam.
  • Supports the identification of critical program risks and develop mitigation path.
  • Support Asset Teams in their design and development strategy for filing and implementing changes by authoring or reviewing sections of regulatory filings applicable to design control, risk management, and specifications; support responses to regulatory questions; participate/support regulatory inspections. Supports SaMD/SiMD development through the review and approval of
  • Supports the QA interface with medical device or device component suppliers and testing partners by providing technical and quality support during the development, testing and manufacture at a supplier site.
  • Prepare and manage development quality agreements.

 

Minimum Education Requirements

  • Minimum educational level necessary to perform the job (High School diploma, Associate’s Degree, Bachelor’s Degree, Masters, PhD) D. Minimum Experience Requirements
  • Minimum experience requirements necessary to perform the job
  • Minimum of a BS in Biomedical/Mechanical Engineering or related technical or scientific disciple or equivalent experience
  • Minimum of 3-6 years in a medical device quality role,
  • Knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971(Risk Management) requirements, Medical Device Regulation (MDR) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
  • Demonstrated ability to work effectively both independently and cross-functional with minmal supervision.
  • Good communication skills, both verbal and written
  • Proven experience in project completion: meeting project goals and milestones

 

JOB SCOPE FACTORS

Scope/Accountability

  • Breadth within the organization for which the employee is responsible, workflow involvement, budgetary responsibility
  • Minimal project management, Quality and technical guidance for medical device development (Samd/SiMD) lifecycle management within PO&T Quality organization.

 

Decision Making, Discretion & Latitude

  • Complexity of problems or procedures encountered, prioritization and decisiveness required to resolve issues.
  • Decision making compensatory with senior level position and responsibilities.
  • Effective matrix support in the setting of program teams across the full product lifecycle, sub-teams, or other cross-functional teams, operating in a matrix environment.

 

Impact/Influence/Liaison

  • Overall impact to the department/business unit/company/external stakeholders; impact/consequence of erroneous work/actions; level of consultation provided to management.
  • Quality representative for SamD/SiMD and integrating hardware for medical device design and development for use with therapies.
  • Ensures adherence to regulatory requirements and internal policies and procedures for product quality, integrity, and compliant development and marketed product.
  • Report to management on a regular, periodic basis for program and process update.

 

Knowledge & Skills

  • Medical device design control quality oversight for design control and risk management of primarily for SaMD and SiMD; medical device engineering technical skills; project management and people leadership expertise.

 

 

If you are interested in hearing more about the position, please respond to the email address with your resume attached 


Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

 

 

Company Description
Looking for a new career, or a change from your current work environment?

The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field

The Fountain Group

Looking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field

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Chicago, IL
60614 USA

Industry

Manufacturing

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