
Medical Device and Diagnostics System Specialist
4 days ago
Key Role:
A highly skilled Opcenter Execution Medical Device and Diagnostics specialist is needed for implementing and upgrading systems.
The ideal candidate will have strong experience in installations, interface configurations, data migrations, and infrastructure understanding within GxP-regulated environments.
Primary Responsibilities:
- Perform system installations and upgrades, including validation and audit documentation.
- Configure interfaces using Opcenter Connect MOM:
- Level 2 integrations via OPC UA for machine connectivity.
- Level 4 interfaces for SAP MES integration.
- Migrate master data and configurations to higher environments (DEV → QA → PROD).
- Collaborate with infrastructure teams to ensure application requirements are met.
- Utilize reporting tools for generating operational and compliance reports.
- Support modeling configurations, such as UDCD, Business Rules, and User Queries.
- Work on Designer and Portal Studio for MAP(XML) configurations, workflows, and other MES components.
- Ensure implementation aligns with regulatory requirements and industry best practices.
Required Qualifications:
- Proven experience with Siemens Opcenter Execution Medical Device and Diagnostics.
- Strong hands-on experience in:
- System 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 MES reporting tools.
- Working knowledge of GxP regulations and validation practices.
Preferred Skills:
- MES modeling (UDCD, business rules, user queries).
- Experience with Designer and Portal Studio (MAP, workflows).
- Knowledge of qualification frameworks (IQ/OQ/PQ).
Desirable Attributes:
- Excellent communication and documentation skills.
- Ability to work independently and collaboratively across teams.
- Analytical and solution-oriented mindset.
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