Medical Device Validation Engineer Job at Realign (Danvers)

Medical Device Validation Engineer

Location

United States , Danvers

Salary:

151800.00 USD / Year

Realign

Expiration Date

Until further notice

Requirements

Prepare TMV protocols and reports and perform Validation
Apply Gage R&R (repeatability & reproducibility)
Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.)

Job Responsibility

Write clear TMV protocols and reports
Create test procedures, acceptance criteria, and validation plans
Interpret test methods, specifications, and engineering drawings
Apply Gage R&R (repeatability & reproducibility)
Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.)
Collaborate with Engineering, Quality, Operations, and R&D
Produce clear, audit ready documentation to meet ISO and regulatory requirements for medical devices
Train operators, engineers, and quality staff on validated inspection methods and best practice

Fulltime

Senior Medical Device Compliance Engineer

The Senior Medical Device Compliance Engineer is responsible for medical device ...

Location

United States

Salary:

130500.00 - 159500.00 USD / Year

SharkNinja

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Biomedical), Quality, or a related technical discipline
5+ years of experience in design controls, and post-market sustaining of medical devices
Strong experience supporting electromechanical medical devices, preferably within consumer electronics or high-velocity product development environments
Deep expertise in design controls and risk management, including ISO 14971, hazard analysis, DFMEA, requirements management, and verification/validation
Experience supporting post-market design changes, including ECNs, root cause analysis, and lifecycle risk management
Experience working with overseas contract manufacturers and distributors, including qualification, process validation review, and ongoing compliance oversight
Working knowledge of biocompatibility, electrical safety, labeling, and component change impact assessments
Strong communication skills and the ability to operate effectively in a complex, matrixed organization
Pragmatic, detail-oriented mindset suited to fast-paced, innovative-driven environments

Job Responsibility

Drive design control execution for multiple concurrent medical device NPD programs, ensuring high-quality, audit-ready technical documentation
Lead and support the creation, review, and approval of Design History Files (DHFs), including design and development plans, requirements, design reviews, risk management files, verification and validation plans and reports, and traceability, ensuring documentation is complete and submission ready
Translate medical device compliance and regulatory requirements into clear, actionable product and engineering requirements
Ensure risk management activities including hazard analysis, DFMEA, and test planning in alignment with QMS processes
Support post-market design changes by driving and reviewing ECNs, root cause analysis, risk reassessment, and associated verification/validation and documentation updates
Serve as a hands-on QMS Compliance leader within cross-functional teams, influencing execution through expertise, collaboration, and clear decision-making in a matrixed environment
Review supplier qualifications, process validations, and manufacturing documentation from OEMs to ensure compliance with medical device requirements
Support internal audits, supplier audits, and regulatory inspections

What we offer

medical insurance
dental insurance
vision insurance
flexible spending accounts
health savings accounts (HSA) with company contribution
401(k) retirement plan with matching
employee stock purchase program
life insurance
AD&D
short-term disability insurance

Fulltime

Clinical Engineering Medical Device Security Engineer II

As our Clinical Engineering Med Device Network Engineer, you will ensure end-to-...

Location

United States , Englewood

Salary:

49.78 - 74.05 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Bachelors degree in HTM, Computer Science, Technology or Business Discipline upon hire or equivalent professional experience required
Minimum of 5-6 years of Clinical Engineering Networking role or equivalent experience required
Experience with HIPAA/HITECH compliance standards required
Valid Driver's License

Job Responsibility

Ensure end-to-end security for medical devices and integrate security systems within our environment
Leverage technology for security testing
Collaborate with regional CE technicians on complex medical device projects
Contribute to remediation documentation with the CE Medical Device Security Team
Manage vendor-related device vulnerabilities
Support the CE IT environment
Provide specialized repair for medical equipment
Collaborate with cross-functional teams to architect solutions that strengthen security controls of network connected medical devices
Test configurations and deploy risk mitigation strategies
Prepare, document and present detailed guidance for system configuration and risk mitigation

What we offer

medical
prescription drug
dental
vision plans
life insurance
paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
tuition reimbursement
retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

Sr Clinical Engineering Medical Device Network Engineer

As our Clinical Engineering Med Device Senior Network Engineer, you will lead re...

Location

United States , Corning

Salary:

46.17 - 68.67 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Bachelors Other HTM, Computer Science, Technology, Business discipline or equivalent professional experience, upon hire
Minimum of 7 Years in Clinical Engineering Networking Role or equivalent experience
Experience with HIPPA/ HITECH compliance Standards
Valid Driver's License

Job Responsibility

Lead regional Clinical Engineering network functions and responsibilities
Collaborate with the CE Medical Device Security Team on remediation solutions
Guide other technicians on complex medical device projects
Manage vendor-related vulnerabilities
Contribute to the design and support of the CE IT environment
Provide specialized repair for medical equipment
Ensure end-to-end security measures are implemented and integrated using the latest technologies
Jointly responsible for enhancing the security of our medical devices, networks, and information
Responsible for resolving complex technical and business issues related to medical device security
All associated Job responsibilities of the Clinical Engineering Medical Device Network Engineer I and II

What we offer

medical
prescription drug
dental
vision plans
life insurance
paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
tuition reimbursement
retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

System Engineer – Software as a Medical Device

In the TRIOS Dx team, we are looking for a highly skilled System Engineer to joi...

Location

Denmark , Copenhagen

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Software Engineering, Electrical Engineering, Computer Science, Systems Engineering, or related field
Experience in complex system architecture or system engineering within regulated industries
Strong understanding of software lifecycle management, requirements engineering, and interface design
Experience working with risk management and design control principles
Ability to structure complex clinical and technical problems into clear, testable system requirements
Strong communication skills and comfort working in cross‑functional environments

Job Responsibility

Define, maintain, and evolve system architecture for SaMD products, ensuring alignment with clinical and business needs
Translate user needs, clinical workflows, and product strategy into system-level requirements and specifications
Collaborate with cross-functional teams — software, QA, data science, design, risk management, and clinical stakeholders — to ensure a cohesive and compliant system design
Drive interface definitions, data flow specifications, and subsystem interactions
Ensure traceability, verification, and validation across the design control framework
Guide engineering teams in applying regulatory expectations such as IEC 62304, ISO 14971, IEC 82304‑1, and relevant cybersecurity guidance
Participate in risk analysis, safety architecture development, and hazard mitigation strategies
Support planning and execution of system-level verification and validation activities
Contribute to continuous improvement of our system engineering practices and design control processes

What we offer

An opportunity to improve the comfort and treatment of patients by making the technology of tomorrow
A rare opportunity to participate in something radically new, both scientifically and commercially
An attractive work environment in an informal atmosphere, among best-in-class colleagues
Competitive employment terms and benefits and a good work-life balance including remote work for up to 2 days per week

Fulltime

Compliance Sme – Medical Device Software

We are seeking a highly skilled and detail-oriented Compliance Subject Matter Ex...

Location

Salary:

Not provided

Codvo AI

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Engineering, Life Sciences, or related field
7+ years of experience in regulatory compliance for medical devices or SaMD
Proven expertise in FDA regulations, ISO 13485, IEC 62304, and ISO 14971
Strong understanding of software development and validation processes
Excellent communication and documentation skills

Job Responsibility

Lead classification and regulatory pathway analysis for SaMD under FDA guidelines, including 510(k) submissions
Facilitate early engagement with FDA through pre-submission meetings
Implement and maintain QMS in accordance with ISO 13485:2016
Oversee document control, change management, and supplier qualification processes
Ensure integration of risk management into QMS activities
Ensure software development processes align with IEC 62304 standards
Manage software safety classification (Class B or higher)
Oversee development planning, requirements analysis, design, implementation, verification, validation, and release
Apply ISO 14971 principles to identify, evaluate, and mitigate risks throughout the product lifecycle
Collaborate with cross-functional teams to ensure risk controls are effectively implemented and documented

What we offer

Opportunity to work on cutting-edge medical technologies
Collaborative and inclusive work environment
Competitive compensation and benefits

Fulltime

Test Engineer – Medical Devices & AI

We are seeking a highly skilled and detail-oriented Test Engineer with a strong ...

Location

Salary:

Not provided

Codvo AI

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field
5–8 years of experience in software testing, preferably in medical devices or healthcare technology
Strong understanding of AI/ML systems, including model validation and bias detection
Hands-on experience with white-box and black-box testing methodologies
Familiarity with SaMD regulations, ISO 13485, IEC 62304, and related standards
Proven track record in verification and validation of regulated software products
Excellent verbal and written communication skills

Job Responsibility

Understand and evaluate the usage of AI/ML models in medical devices, including algorithm behavior, data integrity, and performance under various clinical scenarios
Design and execute comprehensive white-box and black-box testing strategies for embedded systems, cloud-based platforms, and AI components
Apply knowledge of SaMD classification, regulatory frameworks (e.g., FDA, MDR), and quality processes to ensure product compliance and audit readiness
Lead and contribute to verification and validation (V&V) activities across the product lifecycle, ensuring traceability, risk mitigation, and adherence to design controls
Create and maintain high-quality test plans, protocols, reports, and defect logs aligned with regulatory and internal standards
Work closely with product managers, data scientists, software engineers, and quality teams to ensure alignment and transparency throughout the development cycle
Clearly articulate test results, risks, and recommendations to technical and non-technical stakeholders

Fulltime

Robotics Verification & Validation Engineer

We are seeking a detail-oriented and rigorous V&V (Verification & Validation) en...

Location

United States , Burlingame

Salary:

208000.00 - 289000.00 USD / Year

Select Country

Medical Device Validation Engineer

Job Description

Job Responsibility

Requirements

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