Electrical Advanced Quality Engineer - New Product Development Job
Date: Oct 9, 2013
Location: San Jose, CA, US
|Job Title:||Electrical Advanced Quality Engineer - New Product Development|
|Business Unit:||San Jose|
|Business Sub Function:|
|Job Description:||5900 Optical Court|
San Jose, CA 95138
Position: Electrical Quality Engineer - Advanced
The following is not intended to represent an all-inclusive list of job responsibilities, but to outline the ESSENTIAL FUNCTIONS of the position.
Responsible for influencing design durability and usability of new products and line extensions within the new product development environment.
- Monitor and influence progress of R&D projects to ensure sound application of engineering principles, satisfaction of user needs, and clinical relevancy is being achieved.
- Evaluates/improves the robustness of new products/line extensions through design and/or testing
- Predicts potential failure modes of new product design and offers input/improvements to cross functional design team
- Visit clinical facilities and health care providers (HCP) to gather use data to further develop and improve clinical knowledge, use cases, and potential applications for medical devices
- Designs and/or implements methods and procedures for inspecting, testing, and evaluating the consistency and durability of products and/or production and/or test equipment.
- Perform validation for medical devices, ensuring that proposed designs meet or exceed defined user needs
- Perform and/or supervise validation of production processes and/or test procedures/fixtures
- Select, analyze, design, and improve mechanical and/or electrical manufacturing and/or inspection procedures for medical devices.
- 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.
- Analyze and improve computer test software, verification and validation equipment, inspection equipment, and process/manufacturing 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 QC Inspectors, technicians or Quality Engineer based on pre-established performance parameters.
- B.S. in Engineering required (Electrical or Computer Engineering preferred)
- Clinical experience desired
- Process engineer experience preferred
- 5+ years related experience preferred
- Experience with inspection equipment desired
- 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 influence and interact with cross-functional team members
- Ability to manage priorities and workflow in a rapidly changing environment
- 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.
|Percent Travel Required:||10|
Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto
Job Segments: Gastroenterology, Quality Engineer, Developer, Product Development, Quality, Healthcare, Engineering, Technology, Research