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Staff Quality Engineer - Electrical / Software

Company: Stryker
Location: Portage
Posted on: January 1, 2020

Job Description:

Job Description Who we want Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Goal-oriented developers . Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. User-focused creators. People who imagine with the user in mind, developing technology that helps change patients lives. What you will do As a Staff Quality Engineer, you will support the development of one or more products from concept generation through production, having the unique opportunity to realize the entire product lifecycle. Responsibilities: Partner with marketing and design to understand user needs and translate those into engineering specifications that constitute the basis of the design Lead the development of a safety risk management strategy including implementation of risk controls Partner with suppliers and manufacturing to implement robust process controls Develop test protocols that represent real-world use scenarios to verify design inputs Lead component qualification and inspection development activities with suppliers Lead design validation activities including human factors engineering Monitor compliance to Stryker s Quality Procedures and FDA Quality System Regulations (QSR s) as well as all other product-specific standards/regulations and guide the team as necessary. What you need Basic Qualifications: Bachelors Degree in Engineering Minimum 5 years experience in quality, manufacturing, new product development, software or engineering. Preferred Qualifications: Bachelor s Degree in Engineering in one of the following disciplines: Software, Electrical or Computer Science is desired. Ability to think critically, solve complex problems, and work on large cross-functional and diverse teams. Experience within medical device/manufacturing industry preferred. Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard) preferred. Data analysis (statistical analysis, sampling plans, statistical process control, Minitab) experience is preferred. Work From Home: Not availableTravel Percentage: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor s legal duty to furnish information. Responsibilities: Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. User-focused creators. People who imagine with the user in mind, developing technology that helps change patients' lives. What you will do As a Staff Quality Engineer, you will support the development of one or more products from concept generation through production, having the unique opportunity to realize the entire product lifecycle. Responsibilities: * Partner with marketing and design to understand user needs and translate those into engineering specifications that constitute the basis of the design * Lead the development of a safety risk management strategy including implementation of risk controls * Partner with suppliers and manufacturing to implement robust process controls * Develop test protocols that represent real-world use scenarios to verify design inputs * Lead component qualification and inspection development activities with suppliers * Lead design validation activities including human factors engineering * Monitor compliance to Stryker's Quality Procedures and FDA Quality System Regulations (QSR's) as well as all other product-specific standards/regulations and guide the team as necessary. Qualifications: * Bachelors Degree in Engineering * Minimum 5 years' experience in quality, manufacturing, new product development, software or engineering., * Bachelor's Degree in Engineering in one of the following disciplines: Software, Electrical or Computer Science is desired. * Ability to think critically, solve complex problems, and work on large cross-functional and diverse teams. * Experience within medical device/manufacturing industry preferred. * Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard) preferred. * Data analysis (statistical analysis, sampling plans, statistical process control, Minitab) experience is preferred.

Keywords: Stryker, Portage , Staff Quality Engineer - Electrical / Software, Other , Portage, Michigan

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