- M/F/Veteran/Disability.
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Senior Staff Engineer, Quality Assurance
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Senior Staff Engineer, Quality Assurance
2 weeks ago
Stryker Kalamazoo, United StatesWork Flexibility: Onsite · Stryker is hiring a Senior Staff QA Engineer for our Global Quality Operations team in Kalamazoo, MI. · Who we want- · Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend com ...
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Senior Staff Engineer, Quality Assurance
2 weeks ago
Stryker Kalamazoo, United StatesWork Flexibility: OnsiteStryker is hiring a Senior Staff QA Engineer for our Global Quality Operations team in Kalamazoo, MI.Who we want-Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive u ...
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Engineering Manager
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Plant Manager
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Temporary Research Laboratory Technician Ii
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IT Specialist
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Quality Assurance Specialist
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Quality Manager
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Quality Manager
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Abbott Laboratories Sturgis, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Quality Inspector
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Quality Inspector
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Utility, Molding
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Summit Polymers Sturgis, United StatesSummit Polymers is a leading Tier 1 Automotive Supplier of automotive interior systems. As a world-class automotive supplier of injection molded interior trim, we specialize in the engineering, manufacturing, and assembly of feature based registers, consoles and trim panels. · JO ...
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Warehouse Lead
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Abbott Laboratories Sturgis, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Paint Tech
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Summit Polymers Portage, United StatesSummit Polymers is a leading Tier 1 Automotive Supplier of automotive interior systems . As a world-class automotive supplier of injection molded interior trim, we specialize in the engineering, manufacturing, and assembly of feature based registers, consoles and trim panels. JOI ...
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SCADA Project Engineer
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MANN+HUMMEL Portage, United StatesAs worldwide experts in filtration, MANN+HUMMEL develop solutions for vehicles, industrial applications, clean air inside vehicles and the sustainable use of water. With team spirit and an open culture of communication, we are continuously working towards achieving our vision of ...
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Supervisor, Materials
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Summit Polymers Portage, United StatesP01 - Portage, 4750 Executive Drive, Portage, Michigan, United States of America · Req #628 · Summit Polymers is a leading Tier 1 Automotive Supplier of automotive interior systems · . As a world-class automotive supplier of injection molded interior trim, we specialize in the ...
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Process Engineer
1 day ago
SSOE, Inc. Portage, United StatesOverview: · SSOE is hiring for a Process Engineer for our Portage, Michigan location. Local and qualified applicants are encouraged to apply to this exciting opportunity within our Food & Consumer Products Division. · What Makes SSOE a Great Place To Work · You don't have to b ...
Senior Principal Software Design Quality Assurance Engineer - Portage, United States - Stryker
Description
Work Flexibility:
HybridStryker is seeking to hire a Senior Principal Software Design Quality Engineer (Hybrid) in Portage, MI, supporting Stryker's Medical Division to lead software Digital Health projects on new product development projects
Who We Want:
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Quality-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
Design capable Engineers who have the vision to push product designs to their limits to build design quality understanding and improvement.
Collaborative partners.People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do:
Lead quality assurance for new product development for the global Digital Health Portfolio for the Acute Care business at the Medical Division of Stryker.
Collaboratively drive software design, development, verification and validation strategies while aligning with the compliance requirements in the Quality Management Systems.
Collaborate with cross functional stakeholders including marketing, R&D, clinical, regulatory, operations and other core functions to deliver quality products.Lead risk management activities leveraging ISO14971 standards to ensure safe medical products. Analyze and define critical quality attributes for products. Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
Engage in Voice of Customer events to define user needs, usability, market feedback to support DIOVV activities.
Lead Quality Management System process definition and updates for software lifecycles applying software industry practices, compliance standards and guidance (FDA/TGA/EUMDR).Engage in interdivisional, cross-functional project teams to lead product and/or process design and development activities for medical and non-medical software (SaMD, MDDS, AI/ML).Utilize standard software development practices to drive adoption of processes and methodologies like SAFe for mobile development, cloud solutions and applications.
Ensure cybersecurity, data privacy and interoperability of the digital products are designed in.Review software artifacts and drive design review of systems to ensure compliance and traceability.
Mentor other Quality Engineers.
What you need:
Required:
Bachelor's Degree Required. Preference for Computer Engineering, Software Engineering or related.
10+ years of work experiencePreferred:
Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
Demonstrated applied knowledge of software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and Risk assessments.
Demonstrated experience working with software development R&D teams leveraging processes such as SAFe or Agile.
Knowledge of software design and development, release management, defect management and testing tools and processes. (Bitbucket/Github/Jira/Confluence).Knowledge of software technologies for mobile, cloud and AI/ML solutions.
(Amazon AWS/Microsoft Azure/Apple/Android etc.)Thorough knowledge and understanding of US and International Medical Device Regulations (820/IEC 62304/IEC82304)Demonstrated experience participating in both internal and external audits.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).Highly developed problem-solving skills. Strong analytical skills.Demonstrated ability to successfully manage and complete projects in a matrix organization.
Travel Percentage:
20%Stryker 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 employerStryker 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.
