Product Development Engineer

2 weeks ago


Valencia, California, United States HCSINTL Full time
Product/Process Development Engineer

HCSINTL is seeking a highly skilled Product/Process Development Engineer to fill a key role in our organization. As a primary engineering resource, you will be responsible for the development of enhancements and improvements to current technology, new platforms, and derivative products.

Key Responsibilities:
  • Manage projects from concept to design transfer, ensuring design controls are in place and all phases of the product development lifecycle are completed.
  • Understand and mitigate product risks, evaluate safety and effectiveness, and implement proper test plans at various stages of development.
  • Develop and execute test protocols to ensure product safety and efficacy.
  • Collaborate with cross-functional teams, including Marketing, Medical Affairs, and Scientific Affairs, to document user and product requirements.
  • Design, document, and implement methods for production to support new products or product improvements.
  • Support various Quality and Regulatory activities, including audits, preventative and corrective actions, and root cause analysis.
  • Work with Project Management to coordinate testing activities and ensure on-time submission of design projects.
Technical Expertise:
  • Familiarity with 21 CFR 820 and ISO 13485 and 14971 design controls and risk management in the medical device space.
  • Strong technical background in medical device systems engineering, product development workflows, product testing, and manufacturing validation.
  • Proficiency in 3D CAD modeling, preferably Solidworks, and project scheduling.
  • Familiarity with cell culturing and analysis highly desirable.


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