Solution Architect- Product / Process Monitoring and Equipment Management

 The Solution Architect will play a key role in designing and implementing technology solutions for Product/Process Monitoring and Equipment Management within the IT Manufacturing Workstream. This role involves working closely with cross-functional teams, including IT, engineering, facilities and operations, to define and deliver robust, scalable solutions that optimize product manufacturing processes, improve equipment reliability, and ensure compliance with industry standards.

** This role is a hybrid position. Candidate must reside within 2 hours via car of the Cook Medical location and is required to work onsite as needed per Manager expectations.

**For this position, qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

· Requirements Gathering: Work with stakeholders to gather business requirements and translate them into actionable technical specifications for monitoring, data analytics, and equipment management systems.

· System Configuration & Integration: Ensure seamless development, configuration, implementation, integration and administration of product/process monitoring solutions and equipment management systems with existing enterprise platforms, such as ERP, MES, SCADA, and IoT-enabled equipment systems.

· Technology Leadership: Provide technical leadership in evaluating emerging technologies and recommend innovative solutions for process monitoring, predictive maintenance, and equipment lifecycle management.

· Compliance & Quality Assurance: Ensure all solutions comply with medical industry regulations, such as FDA, ISO 13485, and other relevant standards. Work with the quality assurance and regulatory teams to maintain product and system integrity.

· Data Analytics & Reporting: Develop systems for collecting, analyzing, and reporting key process and equipment performance data to improve decision-making, reduce downtime, and optimize manufacturing operations.

· Collaboration: Collaborate with project managers, business analysts, software developers, and other stakeholders to deliver solutions on time and within budget. Must understand business needs and translate those needs into innovative technology solutions engaging as a leader in delivering those solutions.

· Documentation & Training: Create technical documentation, system diagrams, and training materials for end-users and IT staff. Conduct training sessions as needed.

· Continuous Improvement: Identify opportunities for continuous improvement within our Product/Process Monitoring and Equipment Management applications to drive innovation and operational efficiency.

Key Qualifications:

· Education: Bachelor’s degree in Computer Science, Engineering, Information Technology, or a related field. Master’s degree or equivalent experience is a plus.

Experience:

o Minimum 5 years of experience as a Solution Architect or in a similar technical leadership role within the IT, manufacturing, or the medical device industry.

o Experience in product/process monitoring and equipment management solutions, preferably in the context of Medical Device manufacturing. Additionally, expertise in data historian administration, database queries, data historian content, validation, and reports design.

o Strong experience with enterprise systems (e.g., ERP, MES, SCADA, Data Historians, Databases (SQL Server, Oracle) and OPC Servers) and IoT platforms.

o Proven track record of successful solution design and delivery, particularly for highly regulated industries.

Technical Skills:

o Proficiency in cloud computing, data integration, and big data analytics.

o Expertise in industrial automation, predictive maintenance, and real-time process monitoring systems.

o Experience with controls or as an automation engineer

o Familiarity with IoT technologies, sensors, and device management.

o Experience with software development and system integration (APIs, middleware, etc.).

o Familiarity with data modeling, system architecture design, and software lifecycle management.

o Experience in software development lifecycle, computer systems validation, and change control

Soft Skills:

o Strong communication and interpersonal skills to work effectively with cross-functional teams.

o Analytical mindset with the ability to translate complex business problems into technical solutions.

o Detail-oriented with a strong focus on compliance, quality, and system integrity.

o Ability to work independently and manage multiple priorities in a fast-paced environment.

Preferred Qualifications:

o Experience in the medical device or pharmaceutical industry.

o Knowledge of advanced analytics and machine learning as applied to process monitoring and predictive maintenance.