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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.

 

PURPOSE OF POSITION:  The Platform Subsystem Quality Engineer (PQE) is responsible for working directly within the product development team to develop platform level products which will be customized later for an individual medicinal product workstreams. The PQE ensures that Design Controls and Risk Management requirements are consistently employed and applied to their assigned development efforts. The PQE ensures that all Regulatory Requirements are integrated into the Enable Injections medical device design and the Quality Management Systems (e.g., Design Controls, Risk Management, and Statistical Analysis) are compliant at the Platform subsystem Level. 

 

QUALIFICATIONS

 

 

 

Required:

 

  • BS/BA in an Engineering Discipline or a related field or discipline.
  • A minimum of 6 years of relevant experience; allowances for additional education and specialized experience.

 

Preferred:

  • ASQ Certified Quality Engineer (CQE)

 

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.
  • Possesses working knowledge in FDA, CE Regulatory, and New Product Design processes.
  • Demonstrates technical coaching and leadership of peers.

 

RESPONSIBILITIES:

 

  • Ensure product quality targets are achieved by supporting the design and implementation of test plans.
  • Provide the design team with statistical expertise including sample size selection; test method validation strategies and defining evidential requirements to support 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.
  • Provide analysis and evaluations to support investigations, bounding, root-cause investigation and corrective actions per the corrective and preventative action program.
  • Incorporate assessments of operational performance, product quality and the effectiveness of corrective actions into the risk-management documentation for the platform.
  • Support the System Quality Engineer during material review board activities and advise on the impact of non-conforming materials relative to the assigned subsystem’s design intent.
  • 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.
  • Contribute to a dynamic start-up environment.

 

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.