Sr or Principal Catheter Manufacturing Engineer

The Senior or Principal Manufacturing Engineer will be responsible for designing, implementing, testing, and validating, processes, tooling, and fixtures for medical device products from R&D designs through internal manufacturing line creation to commercial release including scale-up plan. Skills / Experience: BS in Mechanical, Manufacturing or other appropriate Engineering degree Oversee production, inspections, and testing of catheter components on an electro-acoustic devices Participate in material selections that may include adhesives, epoxies, polymers, metals, fine electrical wires, and processes that may include grinding, lapping, milling, dicing, bonding, surface treatment, fine wire interconnections, electroplating, and etching Develop optimal processes for bonding materials including cleaning and surface preparation Utilize accurate metrology and statistical methods for process and design improvements; experience with Geometric Dimensioning & Tolerancing (GD&T) Create manufacturing processes, write process instructions, and train assemblers and technicians as required Experience with design for manufacturability, tolerance analysis, cost analysis and working with engineering drawings meeting quality standards Experience with scale-up production and transfer of manufacturing operations Lead process FMEA and testing to support medical device risk analysis Participate in design FMEA Lead process validation activities (DOE, Gage R&R, IQ, OQ and PQ) in cooperation with quality engineering Working knowledge of FDA quality system regulations, GMP, and ISO 13485 requirements Manage suppliers and maintain design control in compliance with QMS Initiate and conduct engineering studies to resolve issues to ensure high quality and high yield production Hands-on and able to design and develop fixture concepts using internal and external resources Comfortable in machine shop Proficient with Solidworks MS degree a plus Experience with medical devices a must Experience with piezoelectric devices a plus Catheter expertise is a must Start up experience a must Qualities: Detailed oriented with excellent problem-solving skills Team player who takes ownership for problems and works well with an experienced multi-disciplinary team Must have a consistent track record of effectively and clearly communicating concepts, ideas and knowledge to other individuals and teams Proficient with standard business software (MS Office, Excel, Outlook etc.) Self-motivated, able to handle multiple projects and meet deadlines in a timely manner High integrity, work ethic, and passion to succeed Salary range: $150-$180K

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