Job Title: Principal Engineer
Location: New Albany, Ohio (On-Site)
Job Summary: We are seeking an experienced technical leader ready to drive successful development of drug delivery device projects. Our team focuses on delivering innovative medical devices from concept through verification, validation, and regulatory approval, impacting device launches globally.
Responsibilities:
- Lead cross-functional teams to develop and launch mechanical and electro-mechanical medical devices, ensuring integration of multiple subsystems.
- Create and assess engineering documentation, including specifications, design documents, test plans, and regulatory documentation in support of device submissions.
- Provide technical guidance to junior engineers, delivering deep expertise in device design, verification, and validation activities.
- Collaborate closely with Marketing, Operations, and Development teams to support project planning, execution, and successful commercialization.
Required:
- Bachelor’s degree in Engineering (or higher) with a minimum of 7 years of experience; or Associate’s degree with 12 years of experience; or High school diploma / GED with 14 years of experience.
- Demonstrated leadership in the development, engineering, and commercialization of electro-mechanical medical devices, including end-to-end project ownership.
- Proven expertise in material and test specification generation, protocol and report writing, process and test development, rapid prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), and FMEA practices.
- Familiarity with regulatory standards including 21CFR820 (Quality System Regulation), ISO 14971 (Risk Management), EU Council Directive 93/42/EEC, and EN 60601 (Medical Electrical Equipment), as well as experience with drug/device combination products and small-scale device assembly.
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 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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