Staff Process Development Engineer

1 week ago

Carlsbad, United States Medres Ltd Full time

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Full time | Carlsbad, CA MedRes is looking for a Staff Process Development Engineer to join our team in our Carlsbad, California, office. The Process Development Engineer is involved in prototyping and develops new manufacturing processes, implements and qualifies production equipment and methods, manages development builds, generates testing protocols and reports, and works with cross functional team of customers, technicians, quality engineers and project managers. Responsibilities include but not limited to

Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions through frequent interaction with customers, R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies. Design and develop fixtures, tooling, and equipment. Develop process specifications which ensure product specifications are met. Perform process characterizations and qualifications (IQ/OQ/PQ). Manage required builds for new product development in a pilot or production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues. Comply with applicable FDA and international regulatory laws/standards. Perform other duties as assigned or required. Experience & Skills

Bachelor’s Degree in engineering or a related technical discipline (preferably Mechanical, Materials or Biomedical). Minimum 5 years of relevant engineering experience, or advanced degree with a minimum of 3 years of relevant engineering experience. 2+ years of experience developing products and/or manufacturing processes in the medical device industry in the field of Nitinol class III devices and/or complex catheters. Knowledge of SolidWorks and engineering statistics. Some experience or knowledge with Coils/Stents/Braid Manufacturing processes such as laser cutting, laser welding (similar/dissimilar materials), heat treatment, electropolishing, braiding, crimping, swaging, cleaning processes, etc. Experience with development and qualification of fixtures/tooling/equipment (IQ/OQ/PQ, support, design). Knowledge of design and process FMEA, process validation, and process control. Knowledge of design for manufacturability and lean methodology. Lean Six Sigma training preferred. Analytical and statistical skills. Excellent communications skills written and oral. Compensation

The estimated salary range for a new hire in this position is $105,000 to $135,000 depending on background and experience.

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