Job Title: Senior Device Engineer
Location: Thousand Oaks, CA (Hybrid)
Job Summary:
- We are seeking a Senior Device Engineer with a strong background in medical device design and development. The successful candidate will be involved in the design, development, and commercialization of drug delivery devices, with a focus on prefilled syringes.
Key Responsibilities:
- Develop test procedures and lead functional test execution
- Manage material inventory for prefilled syringe programs
- Author technical plans and reports
- Perform advanced statistical data analysis
- Support technical assessments and root cause investigations
- Transfer information to manufacturing sites and engage with suppliers
Skills Required:
- Proficiency in CAD/SolidWorks
- Experience in design verification & validation, FMEA
- Ability to generate and maintain design specifications
- Experience in protocol and report writing, prototyping, design of experiments/statistical process control product optimization
- Familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971)
Preferred Qualifications:
- Degree in Mechanical or Biomedical Engineering, or related field
- Experience in the medical device industry and/or regulated work environment
- Excellent written and verbal communication skills
- Experience in development/commercialization of medical devices and knowledge of manufacturing processes
Basic Qualifications:
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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