Production Engineer | Immunicom

ABOUT IMMUNICOM

Founded in 2013 and headquartered in San Diego, California, Immunicom is redefining the limits of immunotherapy through the development of innovative, non-pharmaceutical treatment approaches for cancer, inflammatory diseases, and autoimmune diseases.  The Immunicom leadership team consists of healthcare industry experts who each have over 25 years of global senior executive experience in private and Fortune 50 medical
technology and pharmaceutical companies.

Although team members may have specific roles in accomplishing tasks on the job, the Immunicom team works collaboratively to achieve the Company’s overall clinical and business goals.  Team members are encouraged to work outside of their specific roles to help accomplish tasks for the furtherance of overall corporate objectives. Team members contribute with ideas, suggestions, and effort through effective communication while exhibiting healthy respect for different opinions and individual preferences. Team members work independently with a sense of ownership as well as show ability to participate in group projects and decision-making. Team members demonstrate a sense of responsibility towards accomplishing their tasks and take accountability for their actions.

REPORTS TO

Chief Commercial Officer (CCO)

POSITION DESCRIPTION

The Production Engineer is responsible for planning and maintaining the production schedule of medical devices in accordance with demand for clinical trials and market needs, as well as manufacturing products with utmost efficiency and quality according to planned protocols and specifications using appropriate technologies. They work alongside Quality Control (QC) and Quality Assurance (QA) to ensure superior product quality and performance as
well as compliance with governing laws and regulatory requirements.

POSITION
STATUS

Full Time

LOCATION

San Diego, CA

RESPONSIBILITIES

  • Work in conjunction with various operational departments to plan, coordinate, and execute production processes to produce high quality products
  • Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors
  • Develop operating instructions and equipment specifications for production activities
  • Investigate problems, analyze root causes, and derive resolutions using thorough and compliant documentation (e.g. NCR, CAPA) and reporting methods
  • Build and maintain vendor and contract manufacturing relationships and ensure compliance with Immunicom’s specifications and quality standards
  • Design and oversee compliance testing and certification for internal and external device and bulk packaging, sterilization procedures, and shelf-life testing
  • Participate and assist in regulatory and product development operations
  • Prepare and manage product shipments to clinical trial sites and/or customers internationally
  • Perform other Production, R&D, Operations, and/or Laboratory tasks, as necessary to address business needs

 

REQUIRED QUALIFICATIONS

  • B.Sc. Mechanical, Biomedical, Industrial Engineering, or equivalent
  • 2-5 years of regulated medical device industry experience (i.e. FDA Class II or III devices)
  • Flexible and able to multi-task; work within an ambiguous, fast-moving environment, demonstrate resourcefulness in setting priorities and guiding investment in people and systems
  • Excellent verbal and written communication skills; excellent interpersonal and conflict management skills
  • Able to lift 50 pounds or more

PREFERRED QUALIFICATIONS

  • M.Sc. Mechanical, Biomedical, Industrial Engineering, or equivalent
  • 5+ years of regulated medical device industry experience
  • Previous experience working in a start-up company environment
  • LEAN manufacturing, 6-sigma, or GMP/GLP experience
  • Excellent leadership skills and project management experience
  • Familiarity with CAD software

TO APPLY EMAIL business@immunicom.com