Staff Systems Engineer - Design Control & Risk Management Process Owner (Hybrid - Acton, MA or San Diego, CA)

Insulet Corporation•San Diego, CA

4d•Hybrid

About The Position

The Staff Systems Engineer – Design Control & Risk Management Process Owner is responsible for enterprise ownership of Insulet’s Design Control process series across the full product lifecycle. In this strategic role, the engineer will assess, harmonize, and continuously improve Design Control processes to ensure they remain integrated, compliant, scalable, and audit ready. The role ensures that updates to any part of the system are implemented holistically, sustainably, and aligned with regulatory expectations and business needs. This individual serves as the single point of accountability for the Design Control ecosystem, partnering closely with document owners, Engineering, Quality, Regulatory, Software, Cybersecurity, Human Factors, Operations, and senior leadership. The role ensures alignment with internal QMS requirements and Insulet’s evolving portfolio of hardware, software, wireless connectivity, cloud systems, and cybersecurity sensitive technologies. This position reports to the Senior Manager, Safety & Compliance Engineering within the R&D Systems Engineering Center of Excellence.

Requirements

Minimum Requirements Bachelor’s required (preferred field of study: Computer Engineering), Master's degree would be a plus
10+ years of experience in medical device development, systems engineering, quality engineering, or design assurance.
Deep knowledge of: Medical Device Design Controls (21 CFR 820.30, ISO 13485) Risk Management (ISO 14971) Verification & Validation methodologies Design Transfer
Demonstrated experience as a process owner or SME for regulated processes.
Strong experience supporting internal audits, external audits, and regulatory inspections.
Ability to simplify complex process frameworks and communicate them effectively across cross functional teams.

Nice To Haves

Demonstrated experience owning or leading Design Controls and/or Risk Management processes at an enterprise, multisite, or divisional level.
Proven track record in harmonization, standardization, or process transformation initiatives.
Experience interpreting and applying Design Control and Risk Management requirements across multiple product development lifecycle models (waterfall, Vmodel, agile).
Familiarity with risk management tools (FMEA, FTA, hazard analysis, usability risk assessment, benefit risk analysis).
Experience with PLM/eQMS/ALM and traceability tools (e.g., Polarion, Helix).
Experience delivering process focused training and coaching.
Experience operating in a global, matrixed environment.
Strong systems thinking mindset and ability to assess upstream and downstream implications.
Demonstrated ability to present complex technical and regulatory topics to senior leadership.

Responsibilities

Enterprise Process Ownership Serve as the process owner for the Design Control & Risk Management process series, ensuring end to end clarity, consistency, and regulatory compliance.
Maintain a systems level view of how Design Control processes interact across the product lifecycle, from concept through post market.
Ensure processes remain scalable across multiple product architectures, technologies, and risk profiles.
Contribute to enterprise harmonization efforts by identifying opportunities for simplification and standardization.
Process Maintenance & Periodic Review Lead periodic reviews of Design Control and Risk Management procedures to ensure they remain current, effective, and compliant.
Collaborate with document owners to drive controlled updates to SOPs, WIs, and templates.
Coordinate communication, training, and rollout of updated processes across engineering and quality organizations.
Process Integration & Change Management Evaluate new or revised processes to ensure seamless integration within the Design Control ecosystem without gaps or conflicts.
Drive cross functional alignment when regulatory changes, business needs, or emerging technologies require process evolution.
Conduct upstream and downstream impact assessments to prevent fragmented workflows.
Support change management activities such as process mapping, gap assessments, and adoption planning.
Metrics, KPIs & Executive Reporting Support and maintain QMR KPIs related to Design Control & Risk Management.
Prepare and present monthly and quarterly metric updates and insights to senior leadership, including XLT.
Identify process performance trends, gaps, and improvement opportunities and recommend actions.
Audit Leadership & Regulatory Support Act as the primary representative for the Design Control process series during internal audits, external audits, and regulatory inspections.
Clearly communicate process intent, structure, integration points, and evidence of process effectiveness.
Support responses to regulatory findings, CAPAs, and long term preventive action plans.
Cross Functional Partnership & Influence Partner with Engineering, Quality, Regulatory, Software, Cybersecurity, Human Factors, Operations, and PMO to ensure consistent use of Design Control processes.
Serve as a subject matter expert and coach for process interpretation, application, and compliance expectations.
Deliver targeted training and guidance on Design Controls and Risk Management requirements and tools.
Influence without authority through strong credibility, constructive challenge, and cross functional alignment.