Author: The Hub

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.

Travel Percentage: 10%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 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.