Envoy Medical has a fantastic role available for a high performing, collaborative Design Quality/ Reliability Engineer. This position will analyze the risk of product non-conformances and trends in complaint data including software and hardware related issues. They will also provide risk and reliability engineering support for design and process changes and coordinate efforts between cross functional groups to lead the overall risk management program.
Duties & Responsibilities:
Perform Risk Management activities using FMEA and other methodologies to verify effectiveness of risk mitigations
Technical aptitude to perform required testing to verify effectiveness representing the organization as a technical contact for risk and reliability for processes such as: Nonconformances, Anomaly Dispositions, Deviations, Complaint Formal Investigations, Change Control and CAPA, among others
Lead test method validation activities
Participate in the identification, assessment, and disposition of product issues, software anomalies, design, and manufacturing changes in collaboration with cross functional partners across the organization to assess patient/user risk
Assess risks that were not previously identified, as well as potential risks associated with a market released product, including embedded firmware products and health software products.
Review and analyze field data, discuss the harm severity sources, and estimate the probability or harm occurrence
Author product level risk documentation with traceability for risk management files describing status of risk controls/mitigations according to current standards
Contribute to risk/benefit analysis for medical product and/or system
Bachelor’s Degree in Engineering, Science, or related technical field
Minimum 4 years of work experience in quality, reliability, design assurance, safety, or systems engineering
Experience with Software Application or Embedded Software development and testing in medical devices or other highly regulated industry such as defense or automotive
Experience with and knowledge of medical device standards including ISO 13485 and ISO 14971
Working knowledge of quality system requirements (QSR), good manufacturing practices GMP) and other applicable global regulations
Formal training in quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)
Excellent communication skills (oral and written)
Effective collaborator with demonstrated ability to work cross functionally
Ability to interpret critical aspects of information received from multiple sources
Strong analytical skills and the ability to solve problems through analytical reasoning
ASQ Certification in Quality or Reliability
Physical Job Requirements:
The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Significant Work Activities: Continuous sitting for prolonged periods, Keyboard use (greater or equal to 75% of the workday)
Location: Twin Cities Metro Area
Travel: Yes, <10% of the time
About Envoy Medical Corporation:
Envoy Medical Corporation, headquartered in White Bear Lake, Minnesota, is a privately held hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance and ultimately quality of life. For more information, please visit: www.envoymedical.com.