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Title:  Senior Engineer, Quality

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

SUPERVISOR’S TITLE:  Manager, Quality

Engineering

 

 

PURPOSE OF POSITION:  The Workstream Quality Engineer (WQE) is the liaison between Enable Injection’s platform design teams and the pharma-partner’s combination product team. The WQE collaborates with the pharma-partner to gather requirements while communicating the technical constraints of the assigned platform. The WQE supports risk-management activities by working with the pharma-partner to define severities for identified hazards related to the application and developing quality and regulatory strategies to meet various business objectives for the pharma-partner without compromising the business objectives of Enable Injections. 

 

QUALIFICATIONS

 

 

Required:

  • Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university.
  • A minimum of 6 years of relevant experience; OR master’s degree in related field plus 4 years’ experience.

 

Preferred:

  • ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE) and ASQ Certified Quality Auditor (CQA).

 

Skills & Competencies:

  • Proficiency in MSA principles, Geometric Dimensioning and Tolerancing (GD&T), methods of risk-management, Minitab statistical software, tolerance stack analysis, process and manufacturing controls, software quality concepts, CAPA, non-conformances, post-market surveillance, Microsoft Office tools.
  • Strong analytical and creative problem-solving skills.
  • Excellent verbal communication and technical writing skills.
  • Demonstrates technical coaching and leadership of peers.
  • Proven ability to deliver on quality engineering projects in a timely manner.  

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.

 

RESPONSIBILITIES:

  • Ensure product quality targets are consistently defined and achieved by providing guidance to pharma-partner combination product teams and appropriately communicating requirements to the Platform Systems Engineer.
  • Collaborate with the Platform Systems and Subsystems Quality Engineers to ensure all medicinal product workstream requirements are being appropriately communicated and represented.
  • Support system and subsystem engineers by advising on pharma-partner unique requirements for design and test plan implementation, sample size selection; test method validation strategies and evidential requirements leveraged across all assigned efforts for risk-management claims and mitigations.
  • Guide the identification and traceability of requirements from Feasibility through Design Release.  Ensure platform requirements are defined, verifiable, and are not redundant.
  • Sponsor a robust execution of Risk Management activities throughout all phases of development and assurance the identified risks have been reduced as far as possible.
  • Ensure that requirements are appropriately defined and tested and that the stress-conditions appropriately challenge the design to insure regulatory and pharma-partner needs are satisfied by the assigned subsystems.
  • Guide various process and product development activities through sample-size determination, distribution identification and data analysis; and other means such as the selection, support and appraisal of inspection plans and process controls.
  • Communicate the results of pharma-partner driven tests as they become available to enable Platform Quality Engineers to incorporate those findings into the risk-management program.
  • Proactively communicate project risks and status to management.
  • Manage other job functions and duties; and provide for other product development projects, teams and activities as required.
  • Provide technical guidance and coaching of other engineers.
  • Contributes to project planning and execution to meet schedule and budget requirements.

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  


Nearest Major Market: Cincinnati