Coopersurgical Jobs (NOW HIRING)

Job Summary:
CooperSurgical is a company focused on providing innovative solutions in the medical device industry, and they are seeking a Senior Technical Architect & Developer to support the Windchill PLM platform. This role involves designing, configuring, and developing technical solutions while ensuring compliance with regulatory standards and collaborating with cross-functional teams.
Responsibilities:
• Configure and develop Windchill PLM solutions, including workflows, lifecycle states, attributes, business rules, and integrations.
• Translate approved functional and business requirements into technical designs and system configurations.
• Support integrations between Windchill and upstream/downstream systems (e.g., ERP, QMS, RIM) under established architectural guidance.
• Assist in troubleshooting and resolving system defects, configuration issues, and data inconsistencies.
• Participate in Business Requirements solicitation sessions with business stakeholders, documenting system needs and constraints.
• Support and co-lead Functional Process Definition workshops to define future-state workflows and system behavior.
• Collaborate with Business Analysts to review, refine, and validate requirements, use cases, and functional specifications.
• Ensure requirements are traceable through design, development, testing, and validation deliverables.
• Contribute to validation documentation updates, including URS, FRS, risk assessments, traceability matrices, Configuration Specifications, Technical Specifications, and validation plans.
• Perform Code Review for all code written for use in robots, listeners, integrations, etc.
• Execute and document test cases (IQ/OQ/PQ/UAT) in accordance with IT Change Control and validation procedures.
• Support audit readiness by ensuring system changes are properly documented and compliant with internal procedures.
• Adhere to regulatory standards including 21 CFR Part 11, 21 CFR Part 820, ISO 13485, and applicable global regulations.
• Support system deployments, configuration migrations, and release activities across environments.
• Assist with change impact assessments, release notes, and deployment documentation.
• Coordinate with infrastructure, QA, and business teams to ensure smooth rollout of system changes.
• Create and update system documentation, configuration specifications, SOPs, and Work Instructions related to Windchill functionality.
• Support development and maintenance of end-user training materials and reference guides.
• Assist with end-user onboarding, system demos, and post-deployment support activities.
• Identify opportunities to improve system performance, usability, and process efficiency.
• Support routine system maintenance, periodic reviews, and defect remediation.
• Escalate complex technical issues to senior architects as appropriate, providing background analysis and recommendations.
Qualifications:
Required:
• Working knowledge of Windchill PLM configuration and customization in a regulated environment.
• Understanding of SDLC, DevOps, CI/CD, change control, and system validation concepts.
• Ability to participate in requirements gathering sessions and clearly document outcomes and action items.
• Strong analytical skills with the ability to understand and document business and system processes.
• Experience updating project and validation documentation with attention to detail and traceability.
• Effective written and verbal communication skills, with the ability to collaborate cross-functionally.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Visio).
• Development proficiency with Java/J2EE, HTML, JSON, REST API, XML, and other Web 2.0 technologies.
• Working knowledge of SQL and data analysis (queries, validation, data review).
• 3-7 years of experience supporting PLM, QMS, or other GxP-regulated enterprise systems.
Preferred:
• Familiarity with Azure, Entra ID, Shiboleth, and other modern infrastructure technologies.
• Familiarity with reporting tools (e.g., Power BI).
• Hands-on experience with PTC Windchill.
• Exposure to Windchill Bulk Migrator and other data migration tools.
• Exposure to validation activities and regulated system change management.
• Experience supporting Medical Device or Pharmaceutical industry systems.
• Familiarity with systems such as MasterControl, Veeva, TrackWise, or ERP integrations.
• BA (or equivalent) in Engineering, Computer Science or Business Administration.
• Windchill User (aka Fundamentals).
• Windchill User Manufacturing BOM Specialist Certification.
• Windchill CAD Integration Specialist Certification.
• Windchill Code and Configuration Certification.
• Windchill: Rest Services Certification.
• PMP or equivalent certification.
Company:
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies. Founded in 1990, the company is headquartered in Trumbull, USA, with a team of 1001-5000 employees. The company is currently Late Stage.