Development Engineer I

Artech LLC

Warsaw, IN

JOB DETAILS
SALARY
$55–$58 Per Hour
SKILLS
Analysis Skills, Atlassian JIRA, Biomedicine, Clinical Practices/Protocols, Communication Skills, Cross-Functional, Documentation, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), File Maintenance, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Maintain Compliance, Medical Equipment, Product Design, Product Development, Product Engineering, Quality Assurance, Regulations, Requirements Management, Research & Development (R&D), Risk, Risk Management, Software Design, Technical Writing, Traceability, Usability Engineering, Validation Testing, Verification Engineering, Writing Skills
LOCATION
Warsaw, IN
POSTED
1 day ago

Job Title: Product Development Engineer
Job ID: 37355811
Duration: 06 Months
Location: Warsaw, IN, 46580
Pay Rate:$55.00 - $58.00/hr.

Key Responsibilities

  • Develop and maintain Design History File (DHF) documentation for Software as a Medical Device (SaMD).
  • Create and update user needs, design requirements, software requirements, design inputs, traceability matrices, and risk documentation.
  • Support Risk Management (FMEA), Usability Engineering, and Verification & Validation (V&V) activities.
  • Collaborate with R&D, QA, Clinical, and Regulatory teams to ensure regulatory compliance.

Required Qualifications

  • Bachelor's degree in Engineering or related field (Biomedical preferred).
  • 5+ years of systems design/product development experience in a regulated medical device environment.
  • Hands-on experience with SaMD, DHF, FDA/QMS, and regulatory documentation.
  • Knowledge of ISO 14971; familiarity with ISO 62304 and IEC 62366.
  • Experience with Codebeamer, JIRA, or similar requirements/traceability tools.
  • Strong technical writing, analytical, and cross-functional communication skills.

About the Company

A

Artech LLC