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- System Engineering Leader is responsible for using their broad technical expertise, leadership skills, and medical device development process knowledge to be the technical leader for product development.
- In this role, you are expected to translate voice of customer and stakeholder needs into system and product requirements, identify potential hazards and assesses requirements to ensure product compliance to safety and regulatory standards, drive product design architecture definition, proactively identify technical risks and mitigation pathways, and aid cross-functional engineering teams in developing design specifications for medical device systems with mechanical parts, electronics, software, and/or algorithms.
- The expectation for the System Engineering Leader is that they represent the R&D function on project core teams, act as a leader of technical excellence, and strive for continuous improvement within the Systems Engineering function.
- They will be expected to help identify and prioritize task and resources, and coach junior associates to ensure planned project milestones are met and systems integration activities are identified and fulfilled.
- Demonstrate knowledge of system-level medical device technology with mechanical parts, electronics, software, and algorithms
- Demonstrate knowledge of the medical device product development lifecycle and standards
- Ability to translate voice of customer and stakeholder needs into system and product requirements
- Responsible for coordination of system-level new product development and its integration
- Lead system and product-level feasibility and risks assessments
- Facilitate cross-functional team knowledge sharing and experiences to promote the understanding and resolution of in-market and new product development issues
- Serve as a key resource to examine system level technical issues and bring to resolution
- Identify potential hazards and associated risk control measures
- Demonstrate knowledge of clinical environments and clinical aspects of medical device usage
- Demonstrate knowledge of informal and formal verification and validation system testingIdentify opportunities and drive continuous improvement efforts
- Coach junior associates
- Apply experience in and best practices to experimental design and data analysis
- Must have a Bachelor’s degree in Engineering. A Master's Degree is desired.
- 8-10 years related work experience required (or combination of work experience and advanced degrees).
- Ability to work independently and as a member of a cross-functional medical device team.
- Ability to lead multi-discipline engineering teams that may consist of mechanical engineers, electrical engineers, software engineers, biomedical engineers, and algorithm engineers to meet planned milestones.
- A strong technical background and experience within Systems Engineering – Translation of User/Business Needs to System Requirements, Requirements Management, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Hazards Analysis, and Failure Modes Effects Analysis.
- Experience with new product development milestone planning and project management.
- Excellent cross-functional communication skills, strong technical writing skills, attention to detail, and demonstrated ability to bring clarity to ambiguous areas to drive decisions.
- Demonstrated history of achievement, learning agility, and action orientation.
- Experience with medical device new product development.
- Experience coaching junior associates.
- Experience in making architectural decisions for medical device systems is a plus.
- Hands-on experience with Design for Six Sigma is a plus.
- ID: #23866271
- State: California San diego 92101 San diego USA
- City: San diego
- Salary: Depends on Experience
- Job type: Permanent
- Showed: 2021-12-04
- Deadline: 2022-01-31
- Category: Et cetera