Sr Process Development Engineer
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Sr Process Development Engineer
Title:Sr Process Development Engineer
The DAVIS Companies has partnered with a global leader in the medical device industry by securing a Sr Process Development Engineer. Please review the below description and if interested in this role, please apply with your Word formatted resume with contact information to be reached. You may also follow up with Rich Gardner, Talent Acquisition Manager with your resume at email@example.com.
A high performing individual that will drive the development of medical device manufacturing processes from prototype assembly to production manufacturing. The desired individual will possess a broad range of medical device design and development skills and experience, as well as depth of knowledge of process development, process validation, lean manufacturing methodology, and statistical process control.
Essential Job Duties and Responsibilities
• Develop and document manufacturing processes for medical devices (disposable and reusable), catheters, implants, and/or packaging, from concept through market introduction.
• Drive process design and product design for manufacturability (DFM) to ensure robust and capable manufacturing processes.
• Plan and execute assembly, documentation and qualification of manufacturing line.
• Plan and execute process characterization studies to determine optimal process windows.
• Develop in-process inspections to ensure conformance to product requirements.
• Design and procure process equipment, tooling, fixtures, and assembly aids.
• Implement process improvements and controls to reduce assembly time and drive yield improvements.
• Conduct process risk analysis (PFMEA) for products under development and implement process controls to drive risk mitigations.
• Plan and execute process validations including IQ, OQ, PQ and PPQ activities.
• Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
• Ensure that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.
• Any other duties as assigned.
Education and Experience
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or Ma
• Minimum of 10 years of medical device product and process development experience is required. Catheter, reinforced catheter, balloon catheter experience a plus.
Skills and Abilities
• Demonstrated ability to bring products from concept to market.
• SolidWorks 3D CAD proficiency.
• Familiarity with FDA QSR and ISO 13485 medical device regulations.
• Knowledge of probability and statistics.
• Depth of knowledge in one or more clinical areas; interventional cardiology is desired.
• Depth of knowledge in one or more product areas; catheters is desired.
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