- Ideal candidate will be supporting the development and manufacturing of medical devices in conformance with quality system regulation, ISO 13485, MDD, ISO 14971, IEC 60601 and other Regulatory standards.
- Incumbent will ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
- This person will lead all risk management activities, ensure procedures and files are maintained to State of the Art, and ensure all applicable staff are sufficiently knowledgeable and contributing to streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative healthcare products.
- In addition, they’ll provide guidance for the application of internal development procedures, including design control, to the product development teams across all levels of the organization throughout multiple disciplines including R&D, RA, Program management, and marketing.
- DFSS, ISO 14971, Design Controls, FMEA, DFMEA, DFSS, Six Sigma Black Belt would be ideal, CQE, Reliability Engineering, Statistical Techniques, Sampling Size Justifications, Minitab, Software Validation, and working knowledge of electro-mechanical devices, software validation methods, and/or plastics related to manufacturing processes (i.e. extrusion, injection molding, RF Welding, etc.) familiarity with gage and inspection techniques. Strong collaboration, negotiation, and conflict resolution skills.
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