We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
We are seeking a Medical Device Component Development Engineer to support component development ... Manage project timelines, risks, and cross-functional coordination. * Support Design Verification ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...
Manager Medical Device Software Engineer information
What does a manager medical device software engineer do?
A Manager Medical Device Software Engineer oversees teams that design, develop, and maintain software for medical devices. They ensure that the software complies with regulatory standards, works reliably, and meets the needs of healthcare professionals and patients. In addition to technical leadership, they coordinate with cross-functional teams, manage project timelines, and mentor engineers. Their role is critical in ensuring products are both safe and effective for use in medical settings.
How does a manager medical device software engineer typically collaborate with cross-functional teams during product development?
A Manager Medical Device Software Engineer frequently works alongside teams such as regulatory affairs, quality assurance, hardware engineering, clinical specialists, and marketing. They coordinate software development activities to ensure compliance with industry standards and regulatory requirements, while also aligning software features with clinical and business needs. These managers often lead design reviews, facilitate risk assessments, and ensure effective communication between software engineers and non-technical stakeholders. This collaborative environment is essential for delivering safe, effective, and user-friendly medical devices.
What are the key skills and qualifications needed to thrive as a manager medical device software engineer, and why are they important?
To thrive as a Manager Medical Device Software Engineer, you need expertise in software development, medical device regulations (such as FDA or ISO 13485), and a background in engineering or computer science, often supported by advanced degrees or certifications. Familiarity with tools like version control systems (e.g., Git), embedded systems platforms, and quality management software is essential, along with understanding regulatory documentation processes. Strong leadership, effective communication, and problem-solving abilities distinguish top performers in this role. These skills are crucial for ensuring safe, compliant, and innovative medical device software development while leading teams to deliver high-quality products.
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Full-time
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Job description
We are seeking a Medical Device Component Development Engineer to support component development, product lifecycle management, and engineering change activities for regulated medical devices. The ideal candidate will have expertise in design controls, verification & validation, supplier quality, process validation, and regulatory compliance.
Roles and Responsibilities- Lead component development and engineering change projects from concept to implementation.
- Manage project timelines, risks, and cross-functional coordination.
- Support Design Verification & Validation (V&V), test protocols, and technical documentation.
- Partner with suppliers on component qualification, DFM reviews, tooling, and process capability.
- Support manufacturing transfer, IQ/OQ/PQ, pilot builds, and production readiness.
- Apply Design Controls, PLM, ECO/ECN/ECR, Risk Management, and Quality System requirements.
- Review engineering drawings, GD&T, specifications, and acceptance criteria.
- Drive root cause analysis using CAPA, 8D, 5 Whys, and Fishbone methodologies.
- Communicate project status, risks, and technical recommendations to stakeholders.
- Experience in Medical Device Component Development or Product Development.
- Strong knowledge of:
- Product Lifecycle Management (PLM)
- Design Controls & Engineering Change Management (ECO/ECN/ECR)
- Design Verification & Validation (V&V)
- ISO 14971, DFMEA, PFMEA
- ISO 13485 & FDA 21 CFR Part 820/QMSR
- Supplier Quality Engineering & Design for Manufacturability (DFM)
- Process Validation (IQ/OQ/PQ)
- GD&T and engineering drawings
- Strong project management, communication, and problem-solving skills.
- Experience working with cross-functional teams in a regulated medical device environment.
- Medical Device Product Development
- Supplier Quality & Component Qualification
- Risk Management & Regulatory Compliance
- Manufacturing Transfer & Validation
- Root Cause Analysis (CAPA, 8D)
- Stakeholder & Project Management