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Electrical Advanced Quality Engineer - New Product Development Job

Stryker

Date: Apr 11, 2014

Location: San Jose, CA, US

Requisition ID:25623BR
Job Title:Electrical Advanced Quality Engineer - New Product Development
Division:Endoscopy
Business Unit:San Jose
Business Function:Engineering
Business Sub Function:
Country:United States
State:CA
City:San Jose
Shift:1st
Job Description:5900 Optical Court
San Jose, CA 95138
Stryker Endoscopy

Job Description

Position: Electrical Quality Engineer - Advanced
Department: RA/QA
Exempt/Non-Exempt: Exempt

The following is not intended to represent an all-inclusive list of job responsibilities, but to outline the ESSENTIAL FUNCTIONS of the position.

GENERAL DESCRIPTION:
Responsible for influencing design durability and usability of new products and line extensions within the new product development environment.

ESSENTIAL FUNCTIONS:

- 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.

QUALIFICATIONS:

- 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.
Qualifications/Work Experience:
Percent Travel Required:10


Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto
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