
Medical Device Implementation Lead
8 hours ago
We are seeking a highly skilled professional to lead the implementation and upgrade of Opcenter Execution Medical Device and Diagnostics systems. The ideal candidate should have expertise in system installations, interface configuration, data migrations, and infrastructure understanding, ideally within GxP-regulated environments.
Key Responsibilities:
- Perform Opcenter component installations and upgrades, including documentation for validation and audit purposes.
- Configure interfaces using Opcenter Connect MOM.
- Level 2 integrations via OPC UA for machine connectivity.
- Level 4 interfaces for SAP MES integration.
- Execute master data and configuration migrations to higher environments (DEV / QA / PROD).
- Collaborate with infrastructure teams to ensure application requirements are met, including network, hosting, and database configurations.
- Utilize Siemens standard reporting tools for generating operational and compliance reports.
- Support modeling configurations, such as UDCD, Business Rules, and User Queries – good to have.
- Work on Designer and Portal Studio for MAP(XML) configurations, workflows, and other MES components.
- Ensure implementation aligns with GxP regulatory requirements and industry best practices.
- Understand and support Qualification frameworks for validating system implementations – good to have.
Required Skills and Qualifications:
- Proven experience with Siemens Opcenter Execution MDD - Medical Device and Diagnostics (v8.6 or v2410).
- Strong hands-on experience in:
- Component installations and upgrades.
- Interface configurations (OPC UA, SAP).
- Master data/configuration migrations.
- Solid understanding of infrastructure requirements related to MES (network, database, hosting).
- Familiarity with standard Siemens MES reporting tools.
- Working knowledge of GxP regulations and validation practices.
Preferred Skills:
- MES modelling (UDCD, business rules, user queries).
- Experience with Designer and Portal Studio (MAP, workflows).
- Knowledge of Qualification frameworks (IQ/OQ/PQ).
Soft Skills:
- Strong documentation and communication skills.
- Ability to work independently and collaboratively across cross-functional teams.
- Analytical and solution-oriented mindset.
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