Senior Engineer - Complaints Technical Investigations (Medical Devices)

Location: Thousand Oaks, California, United States; onsite at the corporate headquarters

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead technical investigations of advanced product complaints involving design and usability issues in drug delivery devices.
• Perform root cause and failure analysis using fishbone diagrams, 5 Whys, FMEA, fault tree analysis, risk assessments, and tolerance analysis.
• Lead cross-functional ideation, testing, and feasibility analysis of design solutions to reduce complaints.
• Conduct technical trend and consolidated investigations using statistical and relational data analytics.
• Evaluate returned products, reserve samples, batch records, complaint history, and trends.
• Own CAPAs, prepare investigation reports, support product improvements, and coach and mentor staff.

Requirements

• Doctorate degree; or a master's degree with 2 years of operations experience; or a bachelor's degree with 4 years; or an associate's degree with 8 years; or a high school diploma/GED with 10 years of operations experience.
• 5+ years of complaints or failure analysis investigation experience in a development or manufacturing environment.
• Experience with medical devices, ideally Class II and Class III devices.
• Demonstrated Six Sigma proficiency for root cause analysis and experience with ISO 14971 risk management, system risk analysis, user risk analysis, and DFMEA/FMEA.
• Experience writing protocols and reports, developing and executing tests, and designing experiments.
• Strong technical writing and interpersonal skills; preferred candidates have 10+ years of progressive relevant experience and an advanced science degree.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on improving patient outcomes.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Award-winning time-off plans and career development opportunities.
• Flexible work models may be available where applicable to the specified work location.