Staff Quality Assurance Engineer at Stryker Medical
Posted in Information Technology 30+ days ago.
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Location: San Jose, California
Advanced Quality Engineers are core members of our Sports Medicine new product development teams. Their primary focus is to bring innovative products to market that meet the high-quality standards of our customers.
Stryker Sports Medicine is the fastest growing segment within the Endoscopy business, helping our customers to advance the treatment of sports medicine procedures through advanced technological solutions.
- Identify Critical Quality Attributes and identifies the most effective steps to ensure these attributes are controlled (though inspection, process selection, etc).
- Subject matter expert in risk management practices and concepts. Organize medical risk management boards
- Perform DFMEA analysis early in the project to identify weaknesses in components.
- Familiar with competitor's products design, user interface, and potential failure modes.
- Ensure that Defined User Needs & Design Inputs are complete and accurate
- High level of influence across project team on testing and execution strategy. Participates in Design Verification and Design Experimentation. Help define Verification & Validation protocols.
- Leads Design Validation activities to ensure Defined User Needs have been met
- Understand clinical uses and applications of product. Perform human factors evaluation of product and take steps to address usability concerns
- 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
- Spends time in lab with Design team experimenting with prototypes to proactively identify potential issues, and works with the cross-functional team to determine root causes and implement solutions
- Utilize a variety of statistical methods throughout the design control process to inform product design decisions and to support verification and validation activities
- Help define acceptance activities & inspection of components & assemblies in house (incoming, in-process and final) and at vendors
- Help define process validation to be performed in-house and at vendors
- Help define Customer Preference Testing and Limited Launch parameters
- Research academic and industrial literature to continuously improve and increase engineering tools and knowledge used at Stryker Endoscopy. Participate in division-wide initiatives to increase organizational capacity
- May participate in Major Division Mergers & Acquisition
- Mentors other AQE(s) in the Division
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Networks with internal and external personnel to gather feedback from subject matter experts.
- Post launch monitoring of newly launched product and incorporate lessons learned in future products
- Timely review of documents as agreed upon by the project team
- Typically requires a Bachelor’s/Master’s degree
- 5 years of related experience
- Quality Assurance certification desired.
- Understanding of US and International medical device regulations desired, as well as experience interacting with regulatory agencies (FDA, notified bodies, etc.)
- 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
- Proven ability to handle multiple projects and meet deadlines
- Collaborate with project team to attain shared objectives. Work through difficult decisions requiring a balancing of many factors.
- 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.
- 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.
- 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.
- Must be comfortable in a surgical/cadaveric setting