Assoc Systems Engineer (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

23h•Hybrid

About The Position

Associate Systems Engineer Position Summary The Associate Systems Lifecycle Engineer will support the definition, integration, and characterization of innovative product content. The successful candidate will engage and actively contribute to system engineering activities within Life Cycle Engineering, including root cause investigations and in-depth analysis of product architecture, requirements and risks, aiding the team in effective solutions that adhere to stringent medical device regulations and quality standards. This role requires exceptional analytical, problem-solving, and communication skills to work effectively with multi-disciplinary teams. This role will provide exposure to several aspects of Insulet’s design control and sustaining processes, including but not limited to writing and interpreting requirements, system integration, verification test methods, troubleshooting/design analysis, failure analysis, risk assessment, and design documentation. This position will report to the Manager of Systems Engineering within Systems Life Cycle Engineering.

Requirements

Bachelor degree required (preferred field of study: Biomedical, Electrical, Mechanical, Systems)
Ability to work in a fast-paced, dynamic environment with a passion for continuous learning.
Passionate about improving the lives of others.
Strong technical writing ability.
Experience with lab equipment (testing).
Microsoft office suite (Word, Excel, PowerPoint).

Nice To Haves

1+ years of experience working in the medical device industry/ highly regulated product development industry.
1+ years of experience working directly in a Systems Engineering discipline within product development.
Demonstrates working knowledge of engineering principles and scientific methods.
Hands-on and inquisitive, not being afraid to challenge a design.
General understanding of medical devices and regulations.
Planning and organization skills.
Ability to organize and judge priorities in a dynamic environment.
Strong analytical and problem-solving abilities.
Excellent written and verbal communication skills.
Creative out-of-the box thinker.

Responsibilities

Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement.
Collaborate with cross-functional project teams consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables.
Contribute to design changes for subsystems including requirement refinement, risk reviews, risk mitigations, and system verification plans to verify the design change.
Support functional analysis, timeline analysis, and detailed trade-off studies to drive design improvements and cost-reduction to existing subsystems.
Contribute to troubleshooting system-level issues, perform root cause analysis, and implement effective solutions throughout the development process.
Contribute to risk management activities, including hazard identification and Failure Modes and Effects Analysis (FMEA), throughout the product lifecycle in accordance with ISO 14971.
Work closely with regulatory affairs and quality assurance teams to prepare and maintain the Design History File (DHF) and other technical documentation for regulatory submissions.
Support external audits conducted by regulatory bodies such as the FDA or Notified Bodies.
Author engineering build requests with direct responsibility for managing engineering materials.
Design and set up bench tests in a lab environment.
Author design protocols and reports.
Coordinate testing to ensure compliance with all applicable safety and performance standards.
Contribute to the analysis of test data, interpret results, and formally document conclusions to verify that design outputs meet design inputs.
Provide technical support and expertise to cross-functional teams for post-market surveillance and continuous improvement activities.
Contribute to the analysis and aid in addressing customer complaints and field issues through risk assessments and technical investigations.
Contribute to device and manufacturing process changes, including documentation updates and risk file maintenance.
Highly coachable and receptive to constructive feedback.
Open to guidance and mentorship to achieve professional growth.
Takes ownership of personal development.
Demonstrates the ability to adapt to new technologies and processes.
Strong presentation skills for communicating with large groups, both in person and virtually.