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Sr. Manufacturing Engineer

Company Profile

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

Job summary

The Senior Manufacturing Engineer develops and improves manufacturing processes, techniques and procedures associated with the building and maintaining of medical devices (electromechanical and sterile disposable) used in ongoing clinical trials. The responsibilities of the position require a steady focus on continuous improvement of product quality through leaner concepts and activities.

Summary of essential job functions

  • Develop new processes and procedures for new product lines.
  • Support manufacturing, process validation, development, and product research efforts.
  • Resolve and document technical issues encountered during manufacturing.
  • Create and revise Manufacturing and Testing Work Instructions including visual aids, Specifications, Inspection and Qualification Documentation.
  • Investigate and report field issues, failures and complaints.  Support Quality System Technical Compliance with participation in Material Review Board, Non-Conforming Material Investigations and Corrective and Preventative Action (CAPA) activities.
  • Solve production related problems and document solutions.
  • Participate in design reviews.
  • Facility and Equipment Qualification/Validation.
  • Verify, validate and document product designs.
  • Follow processes and procedures for supporting and developing products.
  • Provide Engineering support for other departments as necessary.
  • Complete other engineering duties as assigned.

Minimum requirements

  • BSME with strong mechanical engineering background
  • Minimum 5-8 years manufacturing engineering experience
  • Understanding of lean manufacturing principles
  • Line support for new devices and finished goods as well as servicing.
  • Ability to read and understand both electrical and mechanical drawings.
  • Experience with product and process validation.
  • Experience generating product development documentation (plans, schedules) preferred.
  • Experience with FDA GMP Part 820, CE, UL and ISO 13485 preferred.
  • Experience with transferring products from design through validation into manufacturing.
  • Experience with high volume medical disposable production lines in and out of ISO Class 7/8 Cleanrooms
  • Knowledge of terminally sterilization processes (ex. Gamma, Eto, etc.)
  • Experience with production automation (i.e Human Interface Systems and or PLCs) desired
  • Experience performing tolerance analysis calculations and studies   
  • In-depth experience designing jigs, fixtures, and tooling using SolidWorks or equivalent 3D modeling CAD software
  • Working familiarity with SPC and process control methodologies
  • Lean Manufacturing, 6 Sigma, 5S+1, Kanban, Poke Yoke, Kaizen process improvement experience
  • Highly experienced user of Microsoft Office Suite to create documentation, spreadsheets, and databases to support Manufacturing operations
  • In-depth knowledge of typical inspection gages and inspection methodologies
  • Knowledge of various manufacturing methods (ex. molding, forming, joining, fabrication processes, heat treating, machining, additive manufacturing, etc.)
  • Proficient in geometric dimensioning and tolerances
  • Must have excellent written and oral communication skills
  • Must possess excellent attention and respect for detail
  • Proven professional qualities including strong initiative, integrity, and the desire / ability to work in a team environment
  • Possess good mechanical aptitude
  • Ability to organize and manage multiple projects simultaneously
  • Promote a positive, professional atmosphere and support activities that enhance the welfare and morale of Inovio employees

 

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