Senior PLM Engineer – Medical Device Development
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Job Location:
Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Summary
We are seeking an experienced Senior Engineer Medical Device Development with strong hands-on expertise across the end to end 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.
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:
o MasterControl QMS document control training change management
o Arena PLM BOMs ECOs configuration and product lifecycle management
o Jama requirements management and traceability matrices
o SolidWorks mechanical design and engineering drawings
Ensure end to end 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 scale up and manufacturing readiness activities.
Required Qualifications
Education
Bachelor s or Master s degree in Biomedical Engineering Mechanical Engineering Electrical Engineering or a related discipline.
5 10 years of hands-on experience in medical device development.
Proven experience working in regulated (GxP) environments.
Direct hands-on experience with:
o MasterControl
o Arena PLM
o Jama
o SolidWorks
Experience with design controls and risk management (ISO 14971).
Technical Skills
Strong understanding of:
o Design Controls & DHF management
o Requirements traceability
o Verification & Validation (V&V)
o 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
