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