Posted in Other 30+ days ago.
Type: Full Time
INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce an efficacious, robust and tolerable immune response. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, Thermo Fisher Scientific, University of Pennsylvania, VGXI, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.
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 with associated packaging. 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, Software Engineering and Usability, 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.
- Prototype multiple design concepts and perform early screening testing to de-risk programs. Develop test methods and equipment as necessary to execute.
- 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. Review manufacturing material purchase and assembly work instructions.
- 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.
- Bachelor's Degree in Engineering or a related field is required. An advanced degree is desirable.
- Minimum 10 years of experience in engineering.
- Minimum 5 years of management experience in the medical device industry required.
- 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.
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, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, 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.
Important notice to employment businesses/agencies
INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO..