About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com. Job summaryThe temporary Manager, Mechanical Engineering, will be responsible for developing, transferring and supporting programs in the development INOVIO’s electroporation devices.
Development of electro-mechanical mechanisms will support the needs of clinical trials and research. The scope will consist of existing products, next generation development and research prototypes and equipment. The candidate will need a thorough understanding of the design control process and product life cycle. Design and qualification experience is fundamental. The temporary Manager, Mechanical Engineering focuses on various manufacturing and design processes, techniques and procedures and completes tasks with a steady focus on continuous improvement of product quality through leaner concepts and activities.The individual shall have lead development of medical devices of similar complexity and scope.
A complete understanding and ability to satisfy all design control aspects is a must. Knowledge of the risk-based approach and FMEA approaches will be needed to complete Risk Management tasks.Essential job functions and duties
- Development of medical device instruments and sterile disposables.
- Experience with developing products from concept through validation and manufacturing.
- Understanding of regulatory requirements such as FDA cGMP, ISO, CE.
- Develop mechanical designs that meet both internal and external customer needs.
- Interface with outside vendors as needed to communicate design requirements and databases to ensure the accuracy of parts and subsystem manufacturing by vendors.
- Perform troubleshooting and problem-solving efforts related to the development projects.
- Support decisions through engineering and analysis data.
- 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 processes.
- Proficient with design systems; Solid Works, Pro E, AutoCAD, etc.
- Experience working with contract manufacturers.
- Manufacturing support for production, QC, and investigations.
- Excellent teamwork, written and verbal communication skills required.
- Lead and support sterilization technology projects for high volume medical device products.
- Demonstrate hands-on technical understanding and provide guidance and training to junior engineers and technicians on test methods and data analysis techniques.
- Drive operational excellence strategies to reduce cost and increase efficiency through product packaging design, process, and manufacturing changes.
- Develop manufacturing processes and equipment with the Manufacturing Engineering team.
- Organize and lead frequent technical reviews.
- Create assemblies and components using SolidWorks.
- Perform tolerance analysis calculations and studies.
- Evaluate early prototypes using INOVIO’s 3D printers.
- Work with project managers on design input requirements.
- Assist regulatory with FDA related questions on submissions.
- Participate in the change control process for review and generation of change orders.
- Work with project managers on DFMEA.
- Lead Mechanical and other V&V activities, such as writing and executing verification protocols and reports as required.
- Support Quality System Technical Compliance with participation in Material Review Board, Non-Conforming Material Investigations and Corrective and Preventative Action (CAPA) activities.
- Participate in design reviews.
- Complete other engineering duties as required by business needs.
Minimum requirements
- B.S. degree in Mechanical Engineering or a closely related field.
- Minimum 8 years of related engineering experience. 3 years of managing projects with cross functional interactions.
- Thorough understanding of ISO13485 quality control and documentation or equivalent standards from other regulated industries.
- Proficiency in SolidWorks and GD&T (Geometric Dimensioning and Tolerancing).
- Proficiency with standard Microsoft Office tools.
- Expert knowledge of mechanical technical principles, theories and concepts.
- Ability to use common tools in machine shop.
- Excellent written and oral communication skills.
- Proven professional qualities including strong initiative, integrity, and the desire / ability to work in a team environment.
- 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.
The hourly range for this role is $78.00 to $92.00. Individual pay decisions ultimately depend on various factors including, but not limited to, relevant experience, knowledge, skills, education, geography, internal equity and alignment with external market data.
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, 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 job. 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.
