Medical Device Engineer Lead Job at Proclinical (Brussels)

Senior Security Engineer – Medical Device Cybersecurity & Compliance

Job Description: Senior Security Engineer – Medical Device Cybersecurity & Compl...

Location

India , Ahmedabad

Salary:

Not provided

Arrow Electronics

Expiration Date

Until further notice

Requirements

Minimum of 6 years of experience in cybersecurity
At least 3 years focused on medical devices, embedded systems, or IoT security
Proven track record in authoring security design, defining technical requirements, and documenting security architectures aligned with regulatory needs
Hands-on experience in embedded system security including secure boot, firmware security, threat modeling techniques (e.g., STRIDE, DREAD), and product-level risk assessments
Strong understanding of IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97
Working knowledge of the medical device product development lifecycle and quality standards like ISO 14971
Demonstrated expertise in vulnerability management and penetration testing of connected products across device and cloud ecosystems
Excellent problem-solving skills, critical thinking, and ability to lead gap analysis and remediation activities in regulated environments
Strong collaboration skills with the ability to influence cross-functional teams including R&D, compliance, and product management

Job Responsibility

Drive end-to-end cybersecurity integration across the medical device product development life cycle
Develop and maintain cybersecurity for medical products, including security requirements specifications, risk assessments, threat models, and product security architecture documentation
Conduct thorough gap assessments to evaluate compliance with IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97 standards, and implement remediation measures
Perform hands-on vulnerability assessments, penetration testing, and secure code reviews of embedded devices, IoMT components, and connected systems
Collaborate closely with development, compliance, and regulatory teams to ensure product security measures meet both internal security policies and external regulatory expectations
Support SBOM management, software supply chain risk evaluations, and third-party component analysis
Provide expert input on secure communication protocols, encryption standards, data protection for both at-rest and in-transit data, and cloud-based connectivity of medical systems
Assist in developing incident response strategies
Contribute to the continuous enhancement of internal secure development processes, tools, and methodologies, while championing security best practices within product teams

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

Senior Medical Device Software Engineer

Join a mission-driven technology team that’s redefining what’s possible in cardi...

Location

United States , Greater Boston area

Salary:

Not provided

Intellias

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Computer Engineering, Electrical Engineering, or related field with 4+ years of relevant experience OR Master’s degree with 2+ years of experience OR PhD with industry or research experience in relevant areas
Advanced proficiency in Python and C++
Strong knowledge of object-oriented design, data structures, and algorithms
Experience in real-time or embedded software development
Familiarity with network communication protocols and hardware–software integration
Experience in implementation Bluetooth stack, maintenance and configuration.
Hands-on experience with ROS, Linux-based development, and/or real-time operating systems
Experience with CI/CD pipelines, Git, and Agile development methodologies
Knowledge of cloud services (AWS or Azure) and scalable software architectures
Excellent communication and collaboration skills within cross-functional teams

Job Responsibility

Lead the design, development, and optimization of high-performance system software
Develop, test, and debug applications that interface directly with embedded and hardware components
Collaborate with multidisciplinary teams—hardware engineers, system architects, product managers, and QA—to define requirements and deliver solutions that meet clinical and regulatory standards
Drive code quality through peer reviews, automated testing, and continuous integration
Mentor junior engineers and promote engineering excellence through knowledge sharing
Document design decisions, development processes, and testing methodologies to ensure traceability and consistency
Troubleshoot complex software issues and deliver timely resolutions in a regulated environment
Participate in lab evaluations, pre-clinical testing, and system demonstrations for stakeholders and clinicians
Stay current on emerging tools, frameworks, and industry best practices to continuously enhance product performance and maintain technical leadership

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

Senior Program Manager- Medical Device

You will be a member of the Project Management Office team that supports the pla...

Location

United States , Alpharetta

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

BS or advanced degree in engineering, or other related technical discipline
8+ years of industry experience in project management
Certification(s) / License(s): Project Management Certification or equivalent required
Experience with new product requirements through Voice of Customer, assessing value of new product opportunities and communicating to leadership
Strong and broad skills using the tools and technique of project management (WBS, risk register, issues log, budget forecasting, etc.)
Ability to lead in the face of ambiguity
Ability to lead large cross-functional teams and drive execution and accountability to ensure on time delivery of key project milestones
Outstanding communication and presentation skills (written and verbal) to all levels of an organization
Must be adept at planning, interpersonal skills, conflict resolution, and organizing teamwork
Ability to travel up to 25% at times, potentially some international

Job Responsibility

Own and drive the portfolio management process and strategy execution
Drive and execute complex projects/programs with excellence through all project stages (Initiation, Planning, Executing, Monitoring and Controlling, and Closing)
Manage stakeholder and project communication (includes updates to leadership, stakeholder alignment on project scope and milestones, and escalation of issues and risks)
Delivers updates on project status at senior-level reviews
Communicates decisions, direction, and issues from governance meetings
Must have the ability to communicate effectively at the C-Suite Level
Coordinate internal and external resources, ensuring projects remain within scope, schedule, and defined budgets, in collaboration with project staff from various functional departments including marketing, quality, clinical, regulatory, design, human factors, packaging, process development, procurement, etc.

What we offer

401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria

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

Medical Device Account Executive

Carex is partnering with a Healthtech AI Med Device industry partner to identify...

Location

United States , Minneapolis

Salary:

90000.00 - 220000.00 USD / Year

Carex Consulting Group

Expiration Date

Until further notice

Requirements

5+ years of Account Executive or full-cycle sales experience, with a strong track record of closing new business
Experience in medical device, healthcare software, SaaS, or related industries preferred
Hunter mentality with a proactive, persistent approach to prospecting and lead generation
Experience selling into health systems, hospitals, or enterprise environments preferred
Strong business acumen and ability to navigate complex sales cycles
Excellent communication, negotiation, and relationship-building skills
Comfort working in a fast-paced, startup-like environment with ambiguity and autonomy
High level of organization, accountability, and CRM discipline
Demonstrated grit, resilience, and strong work ethic
Ability to travel within the assigned territory and reside within the region

Job Responsibility

Drive net-new business across a multi-state territory including Minnesota, Iowa, North Dakota, South Dakota, Nebraska, Kansas, and eastern Montana
Consistently meet and exceed monthly and annual revenue quotas
Identify, prospect, and convert new leads through proactive outreach and relationship-building
Partner with prospective and existing customers to understand needs and deliver tailored solutions
Collaborate with internal teams including Marketing and Sales Engineering to coordinate demos and sales strategy
Negotiate contracts and pricing in partnership with sales leadership
Maintain accurate and up-to-date customer records in CRM tools (e.g., HubSpot)
Represent the organization at industry events, conferences, and onsite demonstrations
Balance inside and outside sales efforts, including virtual selling and in-person meetings
Travel up to 50% as needed across the territory and 50% spent doing prospecting, sales calls, etc via Zoom

What we offer

Uncapped commission structure
New hire guarantees for the first six months
Bonus potential upon exceeding annual targets
Stock options
Paid time off
Healthcare coverage
Parental leave

Fulltime

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Medical Device Engineer Lead

Job Description

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