The Windchill PLM Technical Architect & Developer supports the design, configuration, development, and ongoing optimization of the Windchill Product Lifecycle Management (PLM) platform within a regulated medical device environment. This role focuses on translating approved business and functional requirements into technical solutions, supporting system enhancements, integrations, and validation activities under the guidance of senior architects and product owners.
The position is hands-on and execution-focused, contributing to project delivery, system stability, and continuous improvement while ensuring compliance with regulatory and quality standards.
The Windchill PLM Technical Architect & Developer works closely with Business Analysts, Quality, Regulatory Affairs, Engineering and other business stakeholders to support the implementation, enhancement, and maintenance of the Windchill PLM solution. This role participates in requirements gathering, functional design, system configuration, and development, and supports validation documentation and testing activities required for regulated system changes.
The role collaborates within cross-functional project teams and supports global users while following established architectural standards, governance processes, and validation frameworks.
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Qualifications:
Knowledge, Skills and Abilities:
- 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.
Technical Skills:
- 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).
- Familiarity with Azure, Entra ID, Shiboleth, and other modern infrastructure technologies preferred.
- Familiarity with reporting tools (e.g., Power BI) is a plus.
- Experience documenting process flows, functional designs, and system configurations.
Experience:
- 3-7 years of experience supporting PLM, QMS, or other GxP-regulated enterprise systems.
- Hands-on experience with PTC Windchill strongly preferred.
- Exposure to Windchill Bulk Migrator and other data migration tools strongly preferred.
- Exposure to validation activities and regulated system change management.
- Experience supporting Medical Device or Pharmaceutical industry systems strongly preferred.
Familiarity with systems such as MasterControl, Veeva, TrackWise, or ERP integrations is a plus.
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Education:
- BA (or equivalent) in Engineering, Computer Science or Business Administration preferred
- Windchill User (aka Fundamentals) a plus
- Windchill User Manufacturing BOM Specialist Certification a plus
- Windchill CAD Integration Specialist Certification a plus
- Windchill Code and Configuration Certification a plus
- Windchill: Rest Services Certification a plus
PMP or equivalent certification a plus.
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at [email protected].
Key Responsibilities:
Technical Design & Development
- 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.
Business Requirements & Functional Design
- 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.
Validation & Compliance Support
- 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.
Deployment & Change Support
- 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.
Documentation & Training
- 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.
Continuous Improvement & Operations
- 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.
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Travel:
Travel up to 25% may be required.
Qualifications
Knowledge, Skills and Abilities:
- 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.
Technical Skills
- 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).
- Familiarity with Azure, Entra ID, Shiboleth, and other modern infrastructure technologies preferred.
- Familiarity with reporting tools (e.g., Power BI) is a plus.
- Experience documenting process flows, functional designs, and system configurations.
Experience:
- 3-7 years of experience supporting PLM, QMS, or other GxP-regulated enterprise systems.
- Hands-on experience with PTC Windchill strongly preferred.
- Exposure to Windchill Bulk Migrator and other data migration tools strongly preferred.
- Exposure to validation activities and regulated system change management.
- Experience supporting Medical Device or Pharmaceutical industry systems strongly preferred.
Familiarity with systems such as MasterControl, Veeva, TrackWise, or ERP integrations is a plus.
-
Education:
- BA (or equivalent) in Engineering, Computer Science or Business Administration preferred
- Windchill User (aka Fundamentals) a plus
- Windchill User Manufacturing BOM Specialist Certification a plus
- Windchill CAD Integration Specialist Certification a plus
- Windchill Code and Configuration Certification a plus
- Windchill: Rest Services Certification a plus
- PMP or equivalent certification a plus
