Medical Device Development

Job Summary

We are seeking an experienced Senior Engineer - Medical Device Development with strong hands-on expertise across the endtoend medical device product development lifecycle including design documentation verification & validation (V&V) and regulatory compliance.

The ideal candidate will have deep experience working in regulated medical device environments and hands-on proficiency with QMS PLM requirements and CAD tools such as MasterControl Arena Jama and SolidWorks in alignment with FDA ISO 13485 and applicable IEC standards.

Required Qualifications

Education

• Bachelors or Masters degree in Biomedical Engineering Mechanical Engineering Electrical Engineering or a related discipline.

Experience

• 5-10 years of hands-on experience in medical device development.
• Proven experience working in regulated (GxP) environments.
• Direct hands-on experience with:

• MasterControl
• Arena PLM
• Jama
• SolidWorks

• Experience with design controls and risk management (ISO 14971).

Technical Skills

• Strong understanding of:

• Design Controls & DHF management
• Requirements traceability
• Verification & Validation (V&V)
• Change control and configuration management

• Familiarity with tools such as Altium Windchill Teamcenter Minitab IBM DOORS or Veeva Vault is a plus.

Soft Skills & Competencies

• Strong analytical and problem-solving skills
• Excellent documentation and technical writing abilities
• Ability to work independently and in cross-functional teams
• Strong communication skills with stakeholders and leadership
• High attention to detail with a compliance-focused mindset

Key Responsibilities

Product Development & Engineering

• Lead and contribute to medical device design and development activities from concept through commercialization.
• Develop review and maintain design inputs outputs specifications and technical documentation aligned with user needs and regulatory requirements.
• Perform CAD modeling design updates and engineering drawings using SolidWorks or equivalent mechanical CAD tools.
• Support design verification validation and risk management activities throughout the product lifecycle.

Quality & Regulatory Compliance

• Ensure compliance with FDA 21 CFR Part 820 ISO 13485 ISO 14971 and applicable IEC standards.
• Author review and maintain Design History File (DHF) Device Master Record (DMR) and related technical documentation.
• Support internal and external audits regulatory inspections and submission readiness activities.
• Participate in change management deviation investigations and CAPA processes.

Tools & Systems (Hands-On)

• Actively use and manage documentation and records within:

• MasterControl - QMS document control training change management
• Arena PLM - BOMs ECOs configuration and product lifecycle management
• Jama - requirements management and traceability matrices
• SolidWorks - mechanical design and engineering drawings

• Ensure endtoend traceability across requirements design risk and test artifacts.

Cross-Functional Collaboration

• Work closely with Quality Regulatory Affairs Manufacturing R&D and Clinical teams.
• Collaborate with suppliers and manufacturing partners to support DFM/DFA and production transfer.
• Support technology transfer scaleup and manufacturing readiness activities.