Stryker is hiring a Senior Software Quality Engineer, Design Assurance to support our Medical’s Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.
Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed.
What you will do:
Designed and tested prototypes and components, applying engineering principles to meet sub-system requirements and support product development.
Conducted root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria.
Translated design inputs into engineering specifications, contributing to component-level and system-level architecture and documentation.
Developed software components, estimated development resources, and led code reviews to ensure alignment with design standards and best practices.
Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes.
Created and maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards.
Demonstrated strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions.
Adapted quickly to new systems and processes, showing initiative, ownership, and the ability to prioritize tasks with minimal supervision.
What you need:
Required:
Bachelor’s degree in a science or engineering.
Minimum of 2+ years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT or Systems Engineering.
Preferred:
Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
Experience working through software lifecycle processes (Agile SAFe/Waterfall).
Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.
Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills
Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.
Knowledge from using Application Lifecycle Management /Traceability tools.
$89,300.00 to $193,400.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
...****@*****.*** Job Title: Jr. Lab Technician (Entry Level) Location: Gretna, LA Job Summary: Looking for a Jr... ...control (QC) tasks. Requirements: Bachelor's degree in Biology, Chemistry, or related field Basic lab knowledge...
...Wilmingtons premier locally owned HVAC company, known for exceptional service, a strong company culture, and a... ..., and a team environment where technicians are respected, supported, and valued... ...repairing residential and light commercial HVAC systems while delivering an...
...ELM Logistics is an Amazon Delivery Service Partner looking for enthusiastic, team players to deliver Amazon packages. Delivery Drivers strive to get every Amazon order to the customers door, safely and on-time. This position requires lifting packages up to 50lbs, with...
...youre competitive, coachable, and motivated by face-to-face work, this role can open real doors. The Role As a Direct Appointment Setter, youll work in residential neighborhoods speaking directly with homeowners and scheduling free roof inspections for our in-...
.... We pride ourselves on professionalism, quality, and a teamfocused work culture. Full job description: Were hiring a Janitorial Outside Porter to support daily cleaning and upkeep of commercial facilities. This role focuses on maintaining cleanliness in common...