Mechanical Engineer, Medical Device (Temporary/Contractor)

San Diego, CA

Temporary

Engineering

Mid Level

This temporary position requires to be onsite to our San Diego location.

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 temporary Mechanical Engineer will be responsible for developing, transferring and supporting programs in the development of 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. This individual will need a thorough understanding of the design control process and product life cycle. Design and qualification experience is fundamental. The temporary Staff Process Development Engineer 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

Oversee process development projects from concept to commercialization, ensuring alignment with timelines and regulatory requirements.
Develop PPQ protocol and support execution of PPQ including testing, verification, and documentation activities.
Specification and requirement setting for raw materials, supplies, and equipment.
Develop and analyze product life cycle with emphasis on risk assessment for materials and process.
Assist in the launching of new NPIs through development and scale-up.
Gather and analyze data using statistics, measurement systems analysis, and design of experiments efforts and their associated analysis tools.
Collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless roll out of processes into production.
Optimize and develop equipment and processes through DOEs, CPPs, and CQAs.
Mentor and guide junior specialists, fostering a culture of continuous learning and development within the team.
Follow design, quality, and safety guidelines based on GMP, regulatory, and ISO guidelines and related Quality and Safety Standards and Practices.
Create detailed process documentation including SOPs and Batch Records, and train staff on new processes.
Handles complex issues and conducts thorough evaluations to devise methods and procedures for new assignments. Exercises judgment in selecting and adapting techniques, ensuring work aligns with departmental goals.
Perform other functions and duties as required.

Minimum requirements

Minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or equivalent work experience.
Thorough understanding of ISO13485 quality control and documentation or equivalent standards from other regulated industries.
Proficiency with SolidWorks
Proficiency with standard Microsoft Office tools.
Experience with Master Control or Polarion a plus
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 $60 to $70. 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.

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Benefits

Mechanical Engineer, Medical Device (Temporary/Contractor)

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