Job Title: Engineer
Location: Thousand Oaks, CA (Hybrid)
Job Description:
- As a key member of our Combination Product Operations Development and Lifecycle Management group, you will support senior staff in the design, characterization, and qualification of combination products. This role demands the application of engineering principles, effective coordination, and communication across functions to drive project success.
Key Responsibilities:
- Plan and author technical documentation, including test plans, protocols, reports, and engineering assessments.
- Conduct hands-on testing of autoinjector devices, ensuring safe operation of test equipment and devices containing sharps.
- Analyze and report data, providing recommendations to stakeholders.
- Provide technical input for mechanical issues and execute tolerance and robustness analysis of complex mechanical designs.
- Collaborate with cross-functional teams to ensure product sustainment and improvement throughout their lifecycle.
- Ensure alignment of device platforms to support variations and system deliverable packages.
Basic Qualifications:
- Bachelor of Science in Engineering or Scientific Discipline
- Effective communication skills (oral and written)
- Proficiency in technical writing (protocols, reports, technical assessments, presentations)
- Preferred/Demonstrated Competencies:
- Broad knowledge and expertise in contributing to complex, multi-disciplinary product development efforts
- Experience in drug/device combination product design and development
- Background in medical device development, commercialization, and lifecycle management
- Physical test method development, qualification, and validation experience
- Proficiency in executing lab tests and building test fixtures
- Technical understanding of drawings, including tolerance stacks and robustness analysis
- Familiarity with relevant standards and regulations (e.g., 21CFR820, ISO 13485, ISO 14971)
- Strong decision-making, presentation, and organization skills
- Ability to collaborate effectively with diverse partners and navigate ambiguity
- Track record of successful team collaboration and problem-solving
If you’re passionate about contributing to the development and lifecycle management of combination products, we encourage you to apply. Join us and be part of a team driving innovation and excellence in healthcare.
About SSi People:
With over 25 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.