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• Translating business and user requirements to product requirements.
• Developing the product verification strategy.
• Reviewing verification results to confirm product requirements are met.
• Identifying and mitigating areas of technical risk by following the product design FMEA process.
• Communication of V-model maturity during product development to management
, you should have the following skills and experience:
•Minimum-Bachelor’sDegree in Electronics / Electrical , Master's Degree (Desired)
• Minimum 10+ years’ experience as systems engineer
• Minimum 5+ years’ experience in a Medical / regulated product development/systems environment
• Experienced in Change management (ECR / ECN)
• Knowledgeable in productVerification/Validation(V&V)
• Experienced in Technical Risk Assessment/FMEA
• Requirements management focus/experience using DOORS or similar system
• Ensuring product development compliant to Subpart C of the Quality System Regulation (preferred)
• Experience in Design for Six Sigma (DFSS) methods/tools (Preferred) / Statistical analysis
• Strong Communication and Presentation skills: Ability to present technical data/concepts concisely and effectively to variousaudiences/stakeholders
• Detailed/ Structured documentation practices and decision making
• Functional competencies: Analytical/Fact Based/Logical problem solver
• Should have working experience with the following standards:IEC 60601-1, ISO 14971, ISO 13485
Our hybrid working model is defined in 3 ways:
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