This is an on-site role based at our corporate headquarters in Irvine, CA. The selected candidate must reside in the local region.How you will make an impact: As a Systems Engineer, this individual will be a member of the Research & Development team, responsible for new product design and development, risk management, and product performance improvements for the hardware components of the Cordella platform. This is a collaborative position in which the Systems Engineer will work closely with other hardware and software engineers, quality, regulatory, manufacturing, and other individuals throughout the company.
- Support development and execution of engineering project plans, including designing and conducting experiments, analyzing results and preparing technical reports
- Create work instructions, test methods, models, and prototypes to characterize and support product and process specifications
- Develop and update design control documentation (e.g. requirements, hazard analyses, DFMEAs, UFMEAs) under guidance
- Perform design change impact assessments evaluating effects on risk, requirements, and verification/validation activities
- Ensure adherence to applicable standards, regulatory requirements, and internal procedures throughout development
- Conduct user research and usability evaluations to inform safe and effective design improvements
- Contribute to maintaining the Design History File (DHF), ensuring documentation is complete, accurate, and traceable
- Support system-level problem-solving and contribute to design and development strategies aligned with project objectives
- Coordinate and provide guidance to technicians on test execution and routine R&D support activities
- Evaluate technical inputs and contribute to design recommendations for components and subsystems
- Perform additional duties as assigned
What you'll need (Required): - Bachelor's Degree in Engineering or Scientific field with 2 years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education
What else we look for (Preferred): - Prior experience performing testing to support V&V and risk management activities for medical device development
- Prior experience working within Design Controls and DHF ownership
- Experience with medical devices and FDA quality practices and standards, including ISO 13485
- Prior experience processing, parsing, and analyzing data, including script development for automation and statistical analysis methods using Excel and Minitab
- Demonstrated ability to work independently with minimal supervision
- Strong written and verbal communication skills with the ability to clearly document technical rationale and present findings to cross-functional stakeholders.
- Solid problem-solving, organizational, analytical and critical thinking skills
- Strict attention to detail and commitment to high quality documentation
- Ability to interact professionally with all organizational levels
- Ability to work effectively in a fast-paced, regulated environment while managing multiple priorities.
- Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
- Ability to build productive internal/external working relationships
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $87,000 - $123,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
