R&D Systems Engineer
(US Medical Devices MNC)
- Working with internal and external customers and New Product Development (NPD) teams, turn Customer Needs into requirements and specifications from the product level to the module level.
- Based on intimate knowledge of customers and their environments, work with teams, or develop individually, the appropriate Use Cases for the product.
- Working across a large and diverse team, have responsibility for the creation, maintenance, and traceability of the Product and System level requirements
- Methods will utilize functional decomposition, physical decomposition, context diagrams, activity diagrams, etc.
- Work with the NPD teams and / or outside partners to define and manage parallel development through interface definition and allocation of functionality and performance.
- Use tools such as DOORS to transition to model driven requirements and design.
- As a contributor to the Risk File, develop risk management deliverables in accordance with the Risk Management Plan to confirm a high degree of product safety.
- Provide technical leadership to the development team and drive fact based decisions with the clear and concise understanding of total product, project, and customer impact.
- The challenge will be applying systems engineering skills (particularly through depth of product understanding) to help drive a strong Systems Engineering development approach. The ability to quantify project tradeoffs, interdependencies, and constraints and communicate recommendations to ensure a robust product, in compliance with FDA and other regulatory bodies is critical.
- Bachelor of Engineering (Mechanical / Electrical / Computer / Electronics) with 3 years in Systems Engineering.
- Minimum 2 years’ experience working in cross functional teams consisting of discipline specific design engineers (Mechanical, Electrical & Software Engineers) and familiar with translating the customer and technical design input requirements using systems engineering principles to develop system architecture and specifications with clear boundary conditions.
- Experience of DFMEA and Risk/Hazard Analysis is preferred
- Previous experience with Medical Devices, FDA Regulations or other applicable regulatory requirements, or experience with structured and disciplined development processes is preferred.
- Experience with DFSS tools such as Voice of the Customer, Critical to Quality, Quality Function Deployment and Failure Prediction Analysis will be added advantage.
Interested applicants, kindly send in a copy of your updated resume in WORD document to email@example.com your current and expected remuneration together with notice period required to current employer.
You can also contact Vincent Low for a confidential discussion at 6749 4236.