Sr. Quality Design Assurance Engineer

Position Summary
Join an exciting medical technology company developing innovative procedures and devices to address insulin resistance and restore metabolic health.  This is a unique opportunity for a talented Sr. Quality Design Assurance Engineer to provide hands-on support to product development, sustaining engineering, and quality system activities. The Sr. Engineer will bring subject-matter expertise to establish key specifications and guide teams on conformance and adherence to the same. Working cross-functionally, the Sr. Engineer will be responsible for the optimization and continuous improvement of internal operations to meet department, quality, and company objectives.

Primary Responsibilities
  • Serve as a Quality representative on product development and sustaining engineering project teams, ensuring compliance with Fractyl’s quality expectations.
  • Oversee the execution of all actions required to optimize the quality of our product, managing any associated risk and maintaining compliance with product specifications. 
  • Lead continual optimization of quality system processes and documentation, overseeing the execution of one or more quality system processes (e.g. design controls, internal auditing, CAPA, training, etc.).
  • Participate in design control activities to ensure regulatory compliance (including requirement reviews, reliability, maintainability, producibility, and testability).
  • Develop and oversee a design assurance process that uncovers any potential undiscovered or unidentified design risks as early as possible in the design life cycle.
  • Provide support for, and participate as a subject matter expert, in regulatory audits.
  • Develop and conduct Quality System training programs.
  • Analyze and solve quality-related problems with products and processes
  • Bring a “can do” spirit to work and deliver on other responsibilities as assigned.

Education or Certification Requirements
  • Bachelor’s Degree in Engineering. 
  • Advanced degree a plus.

Professional Work Experience
  • 5+ years quality engineering experience for product development within the medical device, biotech or pharmaceutical industry
  • Hands-on expertise in risk management
  • Experience in biotech, pharmaceutical and/or medical device industries preferred.
  • Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).

Qualifications and Skills
Must have strong working knowledge of:
  • FDA Quality System Regulation (QSR), and
  • ISO 13485, ISO 14971, and IEC 60601, and
  • MDD and/or international medical device regulations.
  • Solid understanding of design controls and experience in facilitating design transfer.
  • Certification in QAE, Auditing, or Six Sigma a plus.
  • Experience as an Internal Auditor with professional training a plus.

Other Essentials and Key Success Factors:
  • Successful track record of working in high-growth and dynamic organizations
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
  • Highest levels of professionalism, confidence, personal values and ethical standards
  • Detail-oriented with solid analytical skills.
  • Strong communication and teambuilding skills.
  • Strong working knowledge of statistical techniques for data analysis, Minitab experience desirable
  • Advanced user of Microsoft Office Suite, Adobe, etc.

  • Minimal travel required.

The description and requirements outlined above are general; additional requirements may apply.

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