Job Description
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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
• Bachelor s or Master s 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.
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
• Bachelor s or Master s 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.
💡 Quick Summary
Seeking a career-building opportunity? The Engineer Medical Device Development position is now open for candidates interested in the Health Jobs sector. This role in Chicago offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Health Jobs is a plus.