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Principal Engineer
Ref No.: 18-14128
Location: Woburn, Massachusetts
Our client, a leading biopharmaceutical company is looking for a Principal Engineer. This is for an initial duration of 12 months and is located in Woburn, MA
 
Top Skill Sets:
  • Must have experience in engineering Facilities and utilities (Water system, HVAC, steam, etc...)
  • Must have experience handling an auditor and understanding the GMP procedures and policies.
  • Must have the technical skills to assist the technicians at the site.
  • Project management experience would be a preferred skill set
  • The Principal Engineer is responsible for managing the maintenance and execute projects related to the Utilities at the biotech manufacturing site.
  • The Principal Engineer will ensure execution of a safe, compliant, effective, efficient, and cost appropriate operations & maintenance programs.
  • Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!
 
Description:
  • Lead teams in the development of drug delivery devices.
  • Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
  • The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.
  • The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
  • The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
 
Responsibilities:
  • Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
  • 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 product development documents for assigned projects.
  • Provide deep technical assistance for junior engineers.
 
Education and other Skills:
  • BS in Engineering and previous experience in a medical device industry
  • 10 years current experience with engineering processes and procedures.
  • Led projects from development through the 510k and PMA approval process.
  • Strong background in engineering and commercialization of electro-mechanical medical devices.
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  • Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Experience in drug/device combination product design and development
  • Familiar with the following standards:
  • Quality System Regulation
  • 21CFR820
  • Risk Management
  • ISO 14971
  • EU Medical Device requirements
  • Council Directive 93/42/EEC
  • Medical Electrical Equipment
  • EN 60601
  • Small scale device assembly experience.
  • 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 please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.