Principal Engineer

Inteldot is seeking an experienced Principal Engineer to work closely with team members to develop detailed engineering specifications, develop and support characterization testing, develop protocols and validation testing.

• →Work cross-functionally with individuals and project teams in Operations, Engineering and Automation.
• →Create and assess product requirements to determine technical coverage and proper integration different subsystems.
• →Create and execute to project plans and schedules.
• →Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related process development documents for assigned projects.
• →Provide deep technical assistance for junior engineers.

• BS in Engineering with previous experience in a Pharma or medical device industry.
• 10 years current experience with engineering processes and procedures.
• Led projects from process development through PPQ approval process.
• Strong background in engineering for combination products.
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Experience in drug/device combination product assembly and packaging.
• Familiar with the following standards: Quality System Regulation 21CFR820, Risk Management ISO 14971, EU Medical Device requirements.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Strong problem solving, risk assessment, and risk management skills.
• Must be capable of working on multiple projects in a deadline driven environment.
• Qualified candidates with strong Electrical Engineering, Mechanical Engineering, Systems/Software Engineering background