Sr. Product Quality Engineer

Sr. Product Quality Engineer

Responsible for developing, applying, revising, and maintaining quality standards for new product development process.

ESSENTIAL FUNCTIONS:
•Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment.
•Analyzes reports and/or returned products and recommends corrective action.
•May interact with customers to solve reliability issues and/or answer general product questions.
•May work from verbal and/or written instructions.
•May train others in quality assurance/GMP related topics.
•Develop and execute process and product protocol.
•Knowledge of applicable domestic and international regulations and standards (QSR,MDD,13485 and CMDCAS).
•Develop statistical process controls and analyze data. Optimize operating parameters.
•Lead, monitor and control progress of projects to ensure sound application of engineering principles used, and design intent is being achieved.
•Select, analyze, design and improve mechanical and electrical manufacturing procedures and engineering systems for medical devices.
•Verify that new engineering devices are technically sound and in compliance with FDA and other regulatory bodies.
•Analyze and improve computer test software verification and validation equipment.
•Perform engineering risk analyses to manage technical difficulties encountered with new medical devices.
•Participate and aid in the new product development process by identifying effective test methods.
•Research academic and industrial literature to continuously improve and increase engineering tools and knowledge used at Stryker Endoscopy.
•Analyze and interpret engineering test data collected during new device testing.
•Interface among multiple departments and teams including R&D, Manufacturing and Quality, vendors and senior managers to ensure specific cost, time and or regulatory standards are met.
•May coordinate the activities of one or more Quality Control Inspectors and/or technicians.
•May evaluate the performance of one or more Q.C. inspectors, technicians or Quality Engineer based on pre-established performance parameters.

Qualifications/Work Experience

•Some Quality Assurance training desired.
•Blueprint/engineering schematic reading and interpretation
•Commitment to excellence and high standards
•Excellent written and oral communication skills
•Excellent organizational, problem-solving, and analytical skills
•Ability to manage priorities and workflow
•Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
•Proficient on basic computer programs Excel, Word, PowerPoint
•Demonstrated ability to operate small hand tools (e.g. pliers, screwdrivers, hammers, wrenches, etc.), power tools and test/inspection equipment.
•Proven ability to handle multiple projects and meet deadlines
•Strong interpersonal skills.
•Ability to deal effectively with a diversity of individuals at all organizational levels.
•Good judgment with the ability to make timely and sound decisions
•Working knowledge of data collection, data analysis, evaluation, and scientific method.
•Demonstrated mechanical/electrical problem solving skills
•Must be able to speak, read, write, and understand the primary language(s) used in the workplace.
•Knowledge of applicable international regulations and standards (MDD, 13485 and CMDCAS)
•Sedentary Work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc. Includes walking around the plant.
•Very good visual acuity.
•The ability to work with and inspect very small objects and/or tools and component parts.
•Must be able to observe and note minute inconsistencies.
•Must be able to generate, follow, and explain detailed instructions and inspection procedures.
•Must be able to complete detailed documentation accurately.
•Must be able to communicate product and/or component part deficiencies to Engineer, subordinate, or supervisory personnel.
•Must be able to analyze and resolve non-routine product issues using independent judgment and inspection equipment.

Education and/or Special Training

•B.S. in electrical, mechanical, computer, or software engineering with 2 or more years experience.