SUMMARY OF ROLE:The Staff Systems Engineer will be responsible for leading and maintaining system architecture, requirements definition, supporting design development, systems integration, verification and validation testing across the product lifecycle for sustaining, product iteration, and next-gen product development. The Staff Systems Engineer will also lead multi-disciplinary projects, root cause issues and analyze product field performance, and develop data driven solutions to drive product improvement impacting performance and safety.
RESPONSIBILITIES:- Lead requirements definition of system, subsystem, interface requirements and supporting definition of design outputs with cross-functional teams (R&D, quality, regulatory, clinical, user experience, manufacturing, etc)
- Lead data analysis on product performance and propose data driven solutions to complex system-level performance and technical issues inclusive of hardware, firmware, algorithm, signal processing, and manufacturing.
- Performs investigation and root cause analysis for field and manufacturing issues.
- Lead design change impact analysis and regression test plans.
- Plan and lead system-level characterization testing and verification & validation testing including protocol and report documentation as well as coordination and execution of internal testing and managing external standards compliance testing as needed.
- Lead multi-disciplinary projects, ensuring scope, schedule and deliverables are met.
- Lead technical and design reviews to present data analysis, project tradeoff studies, drive decisions, and align cross-functional teams.
- Maintaining requirements and verification and validation traceability.
- Support risk management, System Hazard Analysis, and dFMEAs. Identification of risks and proposal of risk-based decisions.
- Maintains up-to-date knowledge of medical devices and technologies related to the company's products.
- Provide peer review of designs and documentation. Mentor junior engineers as the team grows.
QUALIFICATIONS:- BS in Electrical, Mechanical, Biomedical, or Software Engineering. Advanced degree preferred (Electrical Engineering preferred).
- 10+ years of experience in product development of electro-mechanical systems with strong medical device experience.
- Successful track record of defining, developing, testing, and troubleshooting electro-mechanical, firmware and software systems to serve as systems engineering subject matter expert across cross functional teams.
- Demonstrated ability to independently drive projects with rigorous system-level performance analysis with strong technical judgment to guide product design and project decisions.
- Outstanding communication across different stakeholders, departments, and experience levels to drive collaboration, alignment, resolve blockers, and achieve project objectives.
- Experience with requirements management and traceability tools.
- Proficiency in data analysis, processing, visualization, and statistical tools such as: MATLAB, Python, Excel, Minitab etc.
- Strong working knowledge of relevant standards to ensure designs meet compliance (e.g. IEC 60601, ISO 10993, IEC 62304, ISO 14971)
- In-depth experience with QMS, medical product development processes, and design controls.
BENEFITS:Element Science offers a very competitive salary and benefits package including, but not limited to:
- Stock Options
- 90% employer-paid medical, dental, and vision insurance
- Company-paid Basic Life Insurance
- 401(k) retirement plan (Traditional and Roth)
- Competitive Paid Time Off
- Paid Holidays
- FSA (Flexible Spending Accounts)
- HSA (Health Savings Account)
- Employee Assistance Program through PEO
The salary for this exempt-level position will be based on experience and qualifications within an established pay range.
- Pay range: $175,000 - $185,000
