Senior Principal Systems Engineer (Remote/Flexible)

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

Job summary

Join a forward-thinking company as a Senior Principal Systems Engineer, where you will lead system verification activities and collaborate with cross-functional teams to enhance customer experience. This role offers the opportunity to mentor others and develop innovative test methods while ensuring compliance with medical device regulations. With a focus on reliability engineering and continuous improvement, you will play a key role in shaping the future of medical devices. Enjoy the flexibility of remote or hybrid work arrangements while contributing to impactful projects in a diverse and inclusive environment.

Qualifications

• 12+ years of experience in Systems Engineering with multidisciplinary teams.
• Expertise in verification planning under medical device regulations.

Responsibilities

• Lead system verification activities and mentor systems engineers.
• Collaborate with cross-functional teams to meet project deliverables.

Skills

Systems Engineering

Root Cause Analysis

Reliability Engineering

Continuous Improvement Tools

Statistical Analysis

Education

Bachelor’s degree in Systems Engineering

Master’s degree in Engineering

Tools

Minitab

ReliaSoft

Job description

Position Overview:
We are seeking a self-motivated Senior Principal Systems Engineer to join the Life Cycle Engineering team. This role involves leading system verification activities, including test method design, development, execution, and reliability engineering across multiple product lines. The engineer will also participate in root cause analysis and design activities to enhance customer experience. Candidates should have a broad engineering background encompassing software, communications, electrical, mechanical, and materials disciplines.

Responsibilities:

1. Serve as the organization’s spokesperson on specialized projects or programs, acting as a prime consultant on large projects influencing long-term goals, and approve or sign off on managerial documents.
2. Collaborate as a key member of cross-functional teams including electrical, software, mechanical, manufacturing, and quality engineers to meet project deliverables.
3. Lead and mentor other systems engineers within Life Cycle Engineering.
4. Ensure products meet all applicable requirements such as customer specifications, regulatory, environmental, and market needs.
5. Standardize and promote existing test methods, and lead the development of new test methods and risk management activities.
6. Translate test needs into test fixture requirements and specifications.
7. Design test fixtures and verification methods in collaboration with contractors and in-house engineers to ensure quality standards.
8. Lead integration, subsystem, and system verification activities, creating plans, protocols, and reports.
9. Maintain traceability among design inputs, outputs, verification, validation, and risk management artifacts.
10. Mentor individuals across departments on systems engineering best practices.
11. Assist in preparing proposals, project plans, estimates, and communicate progress to leadership and stakeholders.

Education and Experience:

• Bachelor’s degree in Systems, Electrical, Mechanical Engineering, Computer Science, or Biomedical Engineering; Master’s preferred. Certifications in System Engineering are a plus.
• At least 12 years of experience as a Systems Engineer in multidisciplinary teams.
• Minimum of 2 years leading cross-functional development teams.
• Domain expertise in at least two areas among Mechanical, Electrical, Software, and Test Engineering.
• Experience in verification planning and reporting under medical device regulations.
• Familiarity with hazard analysis, fault tree analysis, FMEA, and medical device standards (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820).

Preferred Skills and Qualifications:

• Experience with continuous improvement tools like Six Sigma (Green/Black Belt), Kaizen, CTQ, Critical Parameter Management.
• Proficiency in root cause analysis methods such as Statistical Analysis, Cause and Effect, 5 Whys, 8Ds.
• Knowledge of Reliability Engineering practices including modeling, HALT, and HASS.
• Experience developing FDA-regulated medical devices, especially in drug delivery.
• Familiarity with tools like Minitab, ReliaSoft.

Additional Information:

This position is eligible for 100% remote work or hybrid arrangements. Travel is estimated at 25%, flexible based on business needs.

The US base salary range is $181,200 - $271,800, determined by role, level, location, skills, and experience. Details will be provided during the hiring process.

Insulet Corporation is committed to diversity and equal employment opportunity.