Systems Engineer (Temporary to Full Time)
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 summary
The Systems Engineer (Temp/Contractor) will plan and lead the overall design and development activities relating to the medical device. Define the concept of the device and the design using appropriate standards and input from cross functional teams.
Essential job functions and duties
- Work with marketing to create the User’s Needs Requirements
- Create and manage System level input requirements
- Maintain the Traceability matrix
- Manage and update the Risk Management File such as System Hazard, DFMEA, SW RISK and URRA analysis
- Manage the device user manual
- V&V planning and manage execution
- Update and maintain the Device Master Record (DMR)
- Ensure compliance to FDA and MDDR regulations
- Maintain the device standards list
- Manage external contractors such as Software vendors
- Review software documentation
- Collaborate with cross-functional teams to establish agreement on design implementations
- Work with legal and quality to bring new external vendors on-board
- Complete other engineering duties as assigned.
- B.S. degree in Engineering related field.
- Minimum 5 years of medical device experience.
- Thorough understanding of ISO13485 quality control and documentation or equivalent standards from other regulated industries.
- Understanding of Risk Management based on IEC 14971
- Understanding of IEC 62304 Software life cycle process
- Understanding of Safety standards such as IEC 60601-1 and ISO 11608 for Needle-based injection systems
- Solid understanding of design control based on 21CFR820.11
The hourly range for this role is $56.79 to $72.41 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.