
Associate Principal Engineer,Systems
- Shanghai
- Permanent
- Full-time
- Lead R&D technical team in prdocut development, design transfer and product lauch with high quality delivrables.
- Deliver DHF according to product design and development process, such as system/module requirements, product architecture, low level design of moudles.
- Be responsible for converting user requirements and scenarios to design requirements and technical solutions.
- Be responsible for leading system level and module level design of digital pathology scanner products in project, together with mechanical, electrical, optical, software design team.
- Lead the feasibility study and verficication of new product design in early phase to manage system technical risk.
- Lead the design for reliability and system reliability verification solution, to deliver highly reliable products for customers.
- Lead R&D work in product development and V&V to ensure the product ontime delivery with high quality.
- Lead the technical risk management activities such as DFEMA, DFR, DFM in projects.
- Lead system integration activities such as Alpha sample integration and testing. Resolve the issues found in integration.
- Be responsible for design change process to complete design update and release in NPD/Sustaining projects.
- Expertise in at least one domain in eletronical design, optical design, automation system design, etc.
- Strong understanding and application of System Engineering principles, processes, and procedures.
- Deep understanding in requirement engineering, product development process, design transfer process in medical device projects.
- Skill in system modeling language, such as UML.
- Technical leadership in system planning/integration.
- In-depth knowledge and experience about the medical device related regulations, such as ISO 13485, FDA Title 21 CFR Part 820, ISO 14971, IEC 61010-1 etc.
- Good knowledge about IP and patent management.
- Good team collaboration in cross function team.
- Strong systematic thinking skill.
- Highly self-motivated and commitment to on time delivery.
- Act initiatively and proactively.
- Technical leadership and mentoring.
- Good integrity.
- Demonstrates and applies conceptual and practical expertise in own discipline and is able to apply knowledge in related disciplines.
- Applies knowledge of best practices and analyzes which best practices should be applied in own team to achieve differientation in the market.
- Acts as a resource for colleagues with less experience; may lead small projects with manageable risks and resource requirements
- Demonstrated ability to leverage PSP to solve complex problems independently; takes a new perspective on existing solutions; exercises judgment based on limited set of data.
- Impacts a range of customer, operational, project or service activities within own team and other related teams; works within broad guidelines and policies.
- Explains difficult or sensitive information; works to build consensus.
- Master’s degree or above in Engineering.
- Minimum of eight (8) years of systems engineering and integration experience within medical device field.
- Successful experience in product design, design transfer and design change management in medical device projects.
- At least 2 successful complete product release experiences.
- Fluent English listening, speaking, and writing.