We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. As part of our Quality Engineering team, you will work closely with our R&D and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world.
How you will make an impact:
* Identify and solve complex problems in a multi-stakeholder, team setting where precedent may not exist, using creativity while maintaining compliance with industry regulations.
* Manage cross-functional projects, timelines, and budgets; implement digital quality tools (eQMS, dashboards).
* Translate technical information to all levels of the organization through large and small presentations.
* Independently lead QMS improvement activities and associated projects.
* Own and perform documentation changes and set policies and standards that are followed by others.
* Lead CAPA execution, root cause investigations, and quality data analysis to identify trends.
* Own and drive validation testing (all types), TMV, and software validation testing.
* Lead identification, development, and optimization of complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean tools) for design for manufacturing and continuous process improvement.
* Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc., to improve manufacturing processes and reduce risk.
* Drive development and manage execution of complex experiments and tests (including writing and executing protocols) to validate and improve products and establish robust manufacturing processes; ensure completion of process validations (IQ/OQ/PQ), analyze results, and develop reports.
What you'll need (Required):
* Bachelor's or master's degree in engineering (Mechanical, Chemical, Biomedical, Bioengineering, or other applied sciences).
* 6 years of experience in medical device engineering or medical device quality roles.
* Travel required ~15%.
* Statistical based software (Minitab, JMP)
What else we look for (Preferred):
* Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
* Certified Quality Engineer (CQE) or equivalent.
* Measurement and Test Equipment knowledge and experience are essential.
* Process Validation experience.
* Comprehensive expertise in Quality Engineering principles and applications (CQE body of knowledge).
* Proficiency in quality tools (FMEA, CAPA, statistical analysis).
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.