Work Flexibility: Hybrid
Who We Want:
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop products.
- 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.
What You Will Do:
The Platform Data Systems engineer architects end-to-end platform data solutions that are harmonized across Digital, Robotics, and Enabling Technologies (DRE) medical devices in support of their data use cases.
Technical Competencies:
- Lead technical team members in research, design, development, modification, and evaluation of medical device data systems.
- Apply advanced engineering theories, principles, and concepts across various products within business with respect to data collection, storage and processing.
- Collect data user needs, define use cases, and translate to system requirements.
- Lead platform data system architectural activities.
- Lead the effort to allocate and decompose data requirements on a multi-disciplinary (electrical, mechanical, software) project using modeling, simulation, budgeting, and mathematical techniques.
- Lead Concept Phase activities for data enablement on DRE platforms, technologies, and/or capabilities.
- Lead the definition of required data elements, data structures, and format governance across multiple clinical applications and DRE Platforms.
- Contribute to platform systems exception handling/fault management activities.
- Coordinate a collection of analytical studies, including trade studies, timing studies, sensitivity studies, optimization studies, performance assessments, design assessments.
- Integrate data systems with multi-disciplinary elements.
- Lead verification efforts.
- Contribute to Product Risk Management activities, including identification of failures, mitigations, safety requirements, and design for product safety and security.
- Assess new data enablement technologies and capabilities (prototyping, testing, et.al.) for the organization.
- Mentor and influence in the correction of complex product design issues surrounding current data collection and formatting practices.
- Navigate the Intellectual landscape for filings and protection.
Business Responsibilities:
- Possess an in-depth knowledge of the industry and competitive landscape.
- Partner with customers, internal and external key opinion leaders to develop technical strategies that meet clinical needs.
- Strategize and execute customer facing activities like voice of customer and customer centric design across the business.
- Collaborate on Financial /business modeling and supports business reviews to validate a technical approach.
Med Device Compliance:
- Divisional expert with extensive experience applying industry standards for device development.
- Independent reviewer and advisor for the creation or refinement of engineering documentation, such as the Design History file.
- Lead the development of standards and regulations, working closely with functions within and across business.
General Responsibilities:
- Lead cooperative efforts to ensure the design meets the needs of all stakeholders.
- Lead and support team members to create or improve procedures, policies, processes, systems, and technology requirements.
- Develop and utilize tools to enhance the company’s product/process development or performance.
- Identify and implement design and process solutions and ensures they are sustained over time.
- Lead and support complex product development for cross functional teams, influencing multiple technical areas of expertise.
- Hold team accountable to deliver high quality results with passion, energy, and drive to meet business priorities.
- Mentor, develop and influence across the business, intentionally building divisional relationships.
What You Will Need:
Basic Qualifications:
- Bachelor of Science in Software, Electrical, Mechanical, Systems, Biomedical or Data Engineering
- 8+ years of related work experience
- Ability to communicate complex plans and technical information to team members within and across businesses.
Preferred Qualifications:
Technical Skills:
- Broad base of experience in implementing design methodologies such as DFM, Reliability, Serviceability, and Data Systems Design.
- High degree of experience in medical device design (or designing in a highly regulated industry) and ability to utilize Requirements Management Tools and System Modeling Tools.
Preferred Skills / Engineering tools:
- Requirements Management Software, especially Jama.
- Experience with data processing tools (ie PowerBI)
- Knowledge of data formats (ie JSON)
- Experience with SysML and Model-based Systems Engineering.
- Experience with SysML / MBSE software tools.
- Expert knowledge of ISO 13485 and ISO 14971
- Experience with C++, Python is a benefit
Certifications:
- INCOSE CSEP certified, or equivalent.
More Information
Application Details
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Organization Details
Stryker