Lead Systems Architect
2 weeks ago
Work Flexibility: Hybrid or Onsite
Who We Are Looking For:
- Quality-driven professionals. Individuals who are committed to excellence, thriving in dynamic environments, and dedicated to ensuring projects are completed in accordance with established standards and expectations.
- Innovative thinkers. Engineers who actively pursue the latest research and insights to enhance their software development capabilities.
- Strategic implementers. Engineers who provide clear direction and drive execution to guarantee that products are developed and launched with accuracy.
Technical Expertise:
- Guide technical teams in the design, development, modification, and assessment of design modules, subsystems, or assemblies.
- Convert user requirements into design specifications and create architectural-level layouts and platform designs.
- Capable of architecting complex systems, defining interfaces and dependencies among components, and adeptly resolving intricate system-level challenges.
- Lead and mentor teams to address significant and unique challenges where analysis of situations or data necessitates evaluation of vaguely defined problems.
- Engage with global customers on the system aspects of a robotic platform.
- Design, develop, and implement robotic system hardware, software, and firmware while adhering to company quality standards for effectiveness, reliability, and safety.
- Create and deploy subsystem testing platforms and protocols.
- Collaborate with internal stakeholders and marketing to draft/update customer, system, and subsystem requirements.
- Coordinate with mechanical, electrical, software, and systems engineers to ensure that system and subsystem designs meet specified criteria.
- Analyze system and subsystem requirements to ensure clarity and verifiability, accurately capturing and documenting requirement traceability.
- Integrate post-market data into designs with precision.
- Contribute to the development and execution of plans, protocols, and reports for verification and validation (V&V).
- Utilize common software tools, such as SolidWorks for CAD/CAM, Minitab for statistical analysis, and MATLAB for scripting analysis.
- Apply FDA regulatory guidance, including ISO 13485 / 14971 / 62304, to biomedical device development.
- Collaborate with Quality Assurance in analyzing the device risk management file, including failure modes and effects analysis (FMEA) and fault tree analysis (FTA).
- Work with technical writers to create and update documentation.
- Possess comprehensive knowledge of the industry and competitive landscape.
- Collaborate with customers and key opinion leaders to develop technical strategies that address clinical needs.
- Strategize and execute customer engagement activities, emphasizing customer feedback and customer-centric design across the organization.
- Assist in financial/business modeling and support business reviews to validate technical approaches.
- Lead collaborative efforts to ensure designs meet the needs of all stakeholders.
- Support team members in creating or enhancing procedures, policies, processes, systems, and technology requirements.
- Identify and implement design and process solutions, ensuring their sustainability over time.
- Hold team members accountable for delivering high-quality results with enthusiasm, energy, and a commitment to business priorities.
- Mentor, develop, and influence across the organization, intentionally fostering divisional relationships.
Minimum Qualifications:
- Bachelor's degree in Software, Electrical, Mechanical, Systems, or Biomedical Engineering with 8+ years of relevant experience.
- Ability to convey complex plans and technical information to team members across various departments.
- Develop and utilize tools to enhance product/process development or performance.
- Experience with requirements management tools, such as JAMA, Integrity, or DOORS.
- Proficient in managing product defects using tracking tools like Jira.
- Experience in embedded development using programming languages such as C, C++, and Python.
- Proficient in scripting and analysis using MATLAB.
- Skilled in statistical analysis with Minitab, leveraging data analysis for informed decision-making.
- Broad experience in implementing design methodologies such as DFM, Reliability, and Systems Design.
- Extensive experience in medical device design or in a highly regulated industry, with proficiency in Requirements Management Tools and System Modeling Tools.
- Experience with 3D CAD/CAM software, such as SolidWorks or Creo.
- Familiarity with EDA software, such as Altium.
- Experience with SysML and Model-based Systems Engineering.
- Experience with SysML / MBSE software tools.
- Expertise in 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, collaborating closely with functions within and across the organization.
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.
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