Senior Principal Systems Engineer (Remote/Flexible)

Insulet in; Acton (MA); Hybrid; USD 181,000 - 272,000; Full time

Job summary

An established industry player is looking for a Senior Principal Systems Engineer to join their Life Cycle Engineering team. This role offers the opportunity to enhance customer experience by sustaining and improving on-market products. You will lead system verification activities and engage in critical design processes. With a focus on compliance and risk management, you will collaborate with cross-functional teams to ensure product excellence. This position is ideal for a seasoned engineer with a passion for innovation and a commitment to quality in the medical device sector. Join a forward-thinking company that values diversity and offers flexible work arrangements.

Qualifications

• 12+ years of experience in a multidisciplinary environment.
• Leadership experience in cross-functional teams.

Responsibilities

• Lead and mentor systems engineers supporting Life Cycle Engineering.
• Develop test fixtures and oversee verification activities.

Skills

Systems Engineering

Root Cause Analysis

Cross-Functional Team Leadership

Verification Plans

Risk Management

Education

Bachelor’s degree in Systems Engineering

Master’s degree in Engineering

Tools

Minitab

ReliaSoft

Job description

Senior Principal Systems Engineer (Remote/Flexible) (Finance)

Position Overview:
We are seeking a self-motivated Senior Principal Systems Engineer to join the Life Cycle Engineering team. This role involves sustaining and implementing improvements to on-market products, leading system verification activities, and engaging in root cause analysis and design activities to enhance customer experience. Candidates should have a broad educational and work background across engineering disciplines including software, communications, electrical, mechanical, and materials.

Responsibilities:
• Act as a spokesperson for the organization on specialized projects, acting as a prime consultant and approving managerial output documents.
• Collaborate as a key member of a cross-functional team including electrical, software, mechanical, manufacturing, and quality engineers.
• Lead and mentor other systems engineers supporting Life Cycle Engineering.
• Ensure product compliance with customer, regulatory, environmental, and application-specific requirements.
• Promote and standardize existing test methods; lead the development of new test methods and risk management activities.
• Develop test fixtures and specifications, and oversee verification activities including plans, protocols, and reports.
• Maintain traceability among design inputs, outputs, verification, validation, and risk management artifacts.
• Support proposal and project plan preparations, and communicate progress to leadership.

Education and Experience:
• Bachelor’s degree in Systems, Electrical, Mechanical Engineering, Computer Science, or Biomedical Engineering; Master’s preferred.
• At least 12 years of experience as a Systems Engineer in a multidisciplinary environment.
• Leadership experience in cross-functional teams.
• Domain expertise in at least two areas such as Mechanical, Electrical, Software, or Test Engineering.
• Experience with verification plans, protocols, reports, and medical device regulations.
• Knowledge of hazard analysis and risk assessment tools.
• Familiarity with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820).

Preferred Skills and Qualifications
• Experience with continuous improvement methodologies like Six Sigma; Green Belt or Black Belt certification is a plus.
• Skilled in advanced root cause analysis techniques.
• Knowledge of Reliability Engineering practices.
• Experience in FDA-regulated medical device development.
• Proficiency with tools like Minitab or ReliaSoft.

Additional Information:
This position is eligible for 100% remote work or hybrid arrangements. Travel requirements are approximately 25%.
Salary range in the US is $181,200 to $271,800, depending on role, location, skills, and experience.

Insulet Corporation is committed to diversity and equal opportunity employment. We welcome all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.