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Director, Mechanical Engineering

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, University of Pennsylvania, DARPA, GeneOne Life Science, ApolloBio, Regeneron, 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 Director, Mechanical Engineering plans, oversees, and directs all aspects of mechanical engineering activities related to medical device product development and technology transfer to Production in support of Clinical Trials and Commercial Launch.  The position develops, validates, transfers and supports the transfer of device development and early production of Electroporation devices and sterile disposables.  The position ensures all mechanical engineering projects, initiatives, and processes are in conformance with Inovio’s established policies, objectives, and timelines. The position interacts and collaborates with other functional units, such as Electrical, Manufacturing and Software Engineering, Manufacturing Operations, Quality Assurance & Control, Regulatory, R&D, Clinical Operations and others and interacts with individuals at varying position levels across the company, including senior level executives, outside vendors and contractors. The Director, Mechanical Engineering is responsible for leading, coaching, and developing a team of Mechanical Engineering personnel.

Essential job functions and duties

  • Provide engineering leadership in the development and implementation of approaches that support new and custom product development and sustain and enhance existing products.
  • Develop engineering strategies, plans and programs to support the business goals and objectives and manage product life cycle.
  • Manage mechanical programs for development of new devices and associated disposables.
  • Coordinate with R&D early device development activities in support of Next Generation programs.
  • Provide Program management at systems level for Mechanical, Electrical, Electromechanical and Software aspects.
  • Provide early production sustaining support and future enhancements of existing product lines.
  • Identify and address gaps between future strategic objectives of the organization and current engineering capabilities, competencies and skills.
  • Provide input to develop and effectively manage the department budget, in partnership with Finance.
  • Drive good design practice and discipline in product development.
  • Develop new concepts and aggressively pursue patent protection.  Review Patents with the Legal department.
  • Establish contracts with new outside vendors and manage relationships.
  • Review and sign off design, Quality, Regulatory and Production documents: change orders, drawing, protocols and reports, NCMRs, CAPAs, investigations and complaints related to projects.
  • Partner with Regulatory on a FDA submission path.
  • Write and review SOP’s related to development and production efforts.
  • Act as liaison for engineering for audits by outside regulatory agencies and funding partners.
  • Provide leadership and coaching to other engineers, including evaluating performance, providing feedback, and fostering a culture that promotes development opportunities.

Minimum requirements

  • Bachelor’s Degree in Engineering or a related field is required. An advanced degree is desirable.
  • Minimum 5 years of management experience in the medical device industry required.
  • Overall 10+ years of experience in Engineering.
  • Entrepreneurial / innovative mind-set, with interest in growing a brand and organization.
  • Generation of product development documentation: requirements, plans, specifications & drawings, procedures (test, manufacturing and QC), reports, design reviews and validation.
  • Injection molding, machined components, fabrication and assembly methods.
  • Manufacturing processes and fixture design for reliability.
  • Experience with prototyping methods and process. 
  • Proficiency with FDA regulations and guidelines, cGMPs.
  • Experience in ISO13485 regulated Quality system.
  • Experience in ISO14971 based DFMEA.
  • Proficiency in Human Factors Engineering HE 75 and IEC 62366.
  • A wide degree of creativity and latitude is expected.
  • Excellent teamwork and leadership skills required.
  • Excellent written and verbal communication skills required.
  • Proficient with standard Microsoft Office tools and Statistical Software.

Disclaimer

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.  

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