Job Description

Job description

ABOUT THE ROLE: We have an exciting opportunity for a Principal Systems Engineer that conducts development work as part of a major research and/or development department at Singular Medical. The candidate will lead engineering efforts to develop quality, complex implantable medical devices and their associated platforms.

YOUR RESPONSIBILITIES INCLUDE:

• Work with all stakeholders as appropriate to translate user needs into design requirements (e.g. hardware, software, mechanical, electrical, interface, etc.) consisting of system requirements, sub-system requirements, product/system security requirements, digital architecture, and system interface requirements to define the system as a whole and all associated sub-systems.
• Design, define, and implement system requirements to generate design inputs/outputs, associated processes and working parameters by using current systems engineering methods and technologies. May include simulations, mathematical analysis and/or system interaction analysis.
• Collaborate with Quality Engineering, Design Assurance (DQA) and technical writing staff to produce final product technical document release.
• Solves system problems by analyzing the situation and recommending corrective or alternative actions.
• Analyzes, coordinates system partitioning (i.e. hardware/software partitioning) and total system integration by using systems engineering practices.
• Conducts special studies on subjects such as improving systems engineering practices, improving system quality, subsystem partitioning, etc. by researching and analyzing options for implementation.
• Directs support personnel and project activities.
• Builds Systems Engineering capability by mentoring engineers in engineering activities/methodologies and domain knowledge.
• Analyzes and coordinates industry-based standards testing (e.g. ISO 60601) and associated validation and verification testing and develop associated test plans and procedures.
• Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.
• Assists Regulatory with product submissions.

WHAT WE’RE LOOKING FOR: Required Qualifications

• BS in Electrical, Mechanical, Embedded Software or Biomedical Engineering
• Required minimum years of work experience: 15 years with BS, or 12 years with MS
• Strong engineering skills, specifically with product development, developing high level requirements, design for manufacturability and planning.
• Solid lab experience to develop and debug issues and test equipment.
• Expertise in design simulation tools and analysis techniques.
• Ability to provide technical leadership as it relates to product and process design.
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
• Excellent organizational, communication and collaboration skills.

Preferred Qualifications

• Experience with product development, medical industry products, and systems engineering development.
• Experience with test plans, verification, and validation.
• Experience with product life cycle management process including new product development and sustainment.
• Experience with development of products with safety and hazard analysis and risk management.
• Bilingual in Chinese is a plus.