Senior Systems Engineer, Medical Devices — V&V & Risk

Werfenlife SA.; Bedford, Northern (MA, KY); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

401k with employer match

Paid vacation & sick leave

Job summary

Werfen in Bedford, Massachusetts is seeking a Senior Systems Engineer to support system integration, verification, validation, defect analysis, and remediation across product development. The role translates user needs into test cases, executes testing, and collaborates with cross-functional teams to ensure risk controls and regulatory compliance.

The base salary range is $110,000 to $140,000 per year with comprehensive benefits.

Qualifications

• Bachelor's degree in Engineering, Science or related field is required.
• Eight years of product development or relevant experience; advanced degrees may reduce experience.
• English proficiency required for collaboration and documentation.

Responsibilities

• Owns system-level defect analysis and remediation during SI/ Verification/ Validation.
• Supports Product Risk Management and regulatory compliance activities.
• Conducts DFMEA and risk control verification.
• Translates user needs into system-level test cases with traceability.
• Executes system integration, verification, and validation testing for hardware, software, and interfaces.
• Analyzes test results and supports timely issue resolution.
• Participates in system tests and design reviews focusing on coverage and readiness.
• Communicates complex technical information through docs, presentations, summaries.
• Generates predictable schedules for assigned projects.

Skills

System integration

Verification & validation

DFMEA

Python

Cross-functional collaboration

Regulatory knowledge

Embedded software

Test automation

Issue analysis

Communication skills

Education

Bachelor's degree in Engineering, Science or related field

Tools

Oscilloscope

DMM

Logic analyzer

Digital traceability tools

Job description

Werfen in Bedford, Massachusetts is seeking a Senior Systems Engineer to support system integration, verification, validation, defect analysis, and remediation across product development. The role translates user needs into test cases, executes testing, and collaborates with cross-functional teams to ensure risk controls and regulatory compliance.

The base salary range is $110,000 to $140,000 per year with comprehensive benefits.