Sr. Systems Engineer I

Tandem Diabetes Care

1d•Hybrid

About The Position

This position entails supporting system engineering activities within new or ongoing product development projects. The Sr. Systems Engineer I will work cross-functionally to enhance the definition, design, and development of Tandem’s products. The position will focus on the implementation and maintenance of Medical Device Design Control requirements and best practices. This role will support continuous improvement of both Tandem’s medical devices and associated design and development procedures. The ideal candidate for this Sr SE role will be required to have 3+ years of experience working in the Medical Device industry.

Requirements

Bachelor of Science or equivalent degree in System Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering required.
5+ years’ experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment.
3+ years’ experience working in the Medical Device industry.
Demonstrated capability in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazard analysis and risk assessments.
Ability to dive into the details and analyze different cross functional inputs to produce suitable solutions.
Ability to work independently and deliver a high-quality work product without close supervision.
Ability to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
Ability to effectively convey information related to work product and lead group discussions.

Nice To Haves

Advanced coursework, Master’s degree, or professional licensing in related field desirable.
Experience with requirements management systems (e.g., JAMA, DNG) is highly desirable.
Familiarity with one or more of the following: ISO 13845, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, HIPAA and/or GDPR, preferred.

Responsibilities

Supports the continuous improvement and maintenance of business processes and tools that support Design and Development activities.
Develops and documents system designs and requirements to meet user and business needs for Tandem’s medical device products.
Develops, documents, maintains, and communicates system and subsystem requirements and design, in coordination with various stakeholders such as Engineering, Product Management and Quality Assurance.
Contributes to the development and maintenance of inter-system interface specifications and contracts, considering cross-subsystem impacts.
Contributes to the risk management process and derives risk mitigation requirements.
Provides system expertise to support on-market-products technical support troubleshooting, failure analysis, and triage of system level issues.
Maintains tight collaboration with the teams responsible for product V&V, writes and reviews test plans and protocols, and helps triage issues uncovered during testing activities.
Works closely with the SW and HW development teams to flow down the system and subsystem requirements and assist with establishing traceability.
Traces system and subsystem requirements to the user and business needs defined for the product.
Serves as a key member of a cross-functional project team consisting of product managers, test/quality engineers, development engineers, manufacturing, and other stakeholders.
Identifies and document system interdependencies to mitigate hazards, failure modes, and other risks.
Supports other departments as needed and considers project-wide impacts in decision making.
Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
Mentors more junior system engineers in the performance of their duties.