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We’re looking for people who want to build their best work, work on hard problems, and inspire each other. If that sounds like you, join Medcrypt.
Cybersecurity Quality and Safety Analyst - $110k
The Role Enjoy taking ownership on your projects with an outcome driven mindset? We are looking for a motivated individual to join our team! You will be part of a team that is helping medical device manufacturers (MDMs) understand how to meet cybersecurity regulatory requirements. You will evaluate medical device manufacturers’ cybersecurity designs and regulatory documentation to demonstrate secure, safe and effective devices. The Cybersecurity Quality and Safety Analyst will work closely with the Services leadership team to perform gap analyses, documentation review, architecture analyses and cybersecurity design assessments.
What You’ll Do
- Perform complex risk analyses which also includes risk assessments
- Perform analysis of security design and features in medical device system architectures to identify gaps, flaws, and potential attack surfaces
- Review FDA submission documents related to device instructions for use ), device architecture, and cybersecurity to identify gaps, flaws and other shortcomings in process or description
- Support workshops to resolve documentation and/or design gaps, working collaboratively with the client
- Identify and troubleshoot design gaps in cybersecurity architecture for medical devices when evaluated against best practices/FDA guidance/FDA requirements (per Amendment to the Food, Drug and Cosmetics Act (FD&C Act))/international standards
- Produce security assessments suitable for submission to clients
Qualifications
- Familiarity with FDA guidance documents and/or international cybersecurity standards
- Experience working in regulatory affairs or cybersecurity at an MDM, or similar regulated industry
- Experience applying security principles and best practices to products (medical device experience a plus)
- Excellent written communication skills, critical thinking, and ability to craft documents that clearly communicate to regulatory authorities
- Ability to learn/use a variety of tools for data capture and analysis
- Strong bias for action and ownership
- Familiarity with CVSS specifications and usage for vulnerability assessment and management
Bonus
- Previous exposure to FDA (either at FDA, or engaging with FDA through pre-submissions or premarket filings)
- Certifications in cybersecurity domains Certified Ethical Hacker (CEH), Offensive Security Certified Professional (OSCP), or Certified Information Security Manager (CISM)
To apply: please email your resume to talent@medcrypt.co being sure to include the role in the subject line
Cybersecurity Regulatory Specialist- $175k
As a Cybersecurity Regulatory Specialist, you will be working as a member of MedCrypt’s Services team. In your role, you will help medical device manufacturers (MDMs) understand how to meet cybersecurity regulatory requirements. You will evaluate medical device manufacturers’ cybersecurity designs and regulatory documentation to demonstrate secure, safe and effective devices. The Cybersecurity Regulatory Specialist will work closely with the Senior Director of Cybersecurity Quality and Safety to perform gap analyses, documentation review, architecture analyses and cybersecurity design assessments.
Duties & responsibilities
- Earn trust with clients, get to the true objectives, and deliver creative or innovative solutions to achieve the clients’ objectives
- Review FDA submission documents related to device indications for use (IFU), device architecture, and cybersecurity
- Engage in tabletop exercises and workshops to resolve documentation and/or design gaps, working collaboratively with the client
- Identify and troubleshoot design gaps in cybersecurity architecture for medical devices when evaluated against best practices/FDA guidance/FDA requirements (per Appropriations Bill)/international standards
Qualifications
- Strong experience working in regulatory affairs or cybersecurity at an MDM, or similar
- Excellent written communication skills, critical thinking, and ability to craft documents that clearly communicate to regulatory authorities
- Familiarity with FDA guidance documents and/or international cybersecurity standards
- Ability to learn/use a wide variety of tools for project management, data capture and analysis
- Strong bias for action and ownership
Bonus
- Previous exposure to FDA (either at FDA, or engaging with FDA through pre-submissions or premarket filings)
- Certifications in cybersecurity domains (CISSP or similar) or background in data privacy in healthcare (HIPAA)
How to Apply
Please submit your resume to talent@medcrypt.co, be sure to include the title of the role in the subject line.
Deputy Director Product Cybersecurity Services- $200k
The Deputy Director Product Cybersecurity Services will be tasked with assisting the Senior Director of Product Cyber Security with leading consulting engagements and mentoring junior security engineers in consulting with medical device manufacturers on a wide variety of medical device related technology, process, and regulatory issues to ensure protection safeguarding against potential cyber threats. This will include the review of cybersecurity vulnerabilities and assessing the likelihood of exploitation and any potential impacts to the safety and effectiveness of our clients’ medical devices. The Deputy Director will also provide critical planning for products and services in conjunction with the Senior Director of Cyber Security Product Services to enable growth of product security services and enable Medcrypt core product sales and marketing. A key part of this position is ensuring that our clients activities produce actionable information as supporting proof of device patient safety or efficacy of remediations to enhance the patient safety posture of the product.
Responsibilities
- Provide cybersecurity expertise and leadership across major portions of complex projects;
- Provide technical consulting, leadership and advice to peers and program management;
- Apply understanding of product/line and clinical applications to identify potential cybersecurity threats and develop mitigations;
- Engagement in and strong bias for action and ownership
- Demonstrated skill for independent analysis and synthesis of solutions to complex problems exhibiting creativity, foresight, innovation, and judgement;
- Aid in marketing our services by Informing potential customers;
- Earn trust with clients, and deliver creative or innovative solutions to achieve the clients’ objectives
- Understand interdependencies of processes required to accomplish individual and team objectives.
- Support process definition and improvements;
- Independently plan and manage your own work activities to given project objectives and lead cross functional teams on projects of significant scope at module level;
- Effectively manage projects and staff allocations to ensure success for clients and growth opportunities for team members;
- Identify and sustain client, supplier, and partner relationships;
- Capture new client opportunities by rapidly converging on the project needs, identifying the true objectives, and determining the appropriate resources to complete successfully;
Qualifications
- Bachelor’s degree in a major science or engineering discipline (e.g., Cybersecurity, Systems, Biomedical, Electrical, Mechanical, Software, IT) or related field;
- Experience with cybersecurity regulations and standards such as NIST Risk Management Framework, TIR 57, TIR 97, and ISO 27001, MDR, FDA Guidance;
- Extensive overall cyber security experience in a regulated environment;
- Excellent oral, written, and listening skills;
- Strong persuasion and consensus building skills with the ability to work in cross functional teams;
- Working knowledge of MS office applications, Google Office apps, and statistical analysis skills;
- Ability to independently plan and manage own work activities to achieve group and corporate objectives;
- Strong competency in Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values.
Please submit your resume to talent@medcrypt.co, be sure to include the title of the role in the subject line.
Embedded Software Development Engineer Level I- $135k
Who are you? A talented embedded software development engineer, who will expand our team. We are working to help medical device manufacturers more easily cryptographically secure their products. You build native C/C++ software libraries and applications for a broad range of hardware targets. A successful addition to our team will contribute to the design and implementation of these solutions.
Roles and responsibilities:
- Contribute to MedCrypt’s core mission; our community of engineers is dedicated to ensuring patient safety by implementing proactive security
- Be committed to a deep understanding of cybersecurity technology
- Translate high level designs and requirements into a effective source
- Effectively prioritize and execute tasks in a dynamic, startup environment
- Convey ideas to improve our conventions, processes, software, and products
Your qualifications:
- 3+ years of Software Engineering or related work experience
- 1+ years with C++
- 1+ years with C
- Familiarity with designing, building, and consuming APIs
- Familiarity with nix
- Experience with Git or other SCM
- Extra Points
- Bachelor's degree in Engineering, Computer Science, or a related field
- Experience with autotools and/or cmake build systems
- Experience working with cryptographical hardware elements such as TPMs and HSMs
- Understanding of standard cryptographic operations and PKI
To apply: please forward your resume to talent@medcrypt.co and be sure to include the role in the subject line
Junior Software QA Engineer- $90k
Who are you? You’re an outstanding QA Engineer. You love designing, documenting and testing features that our engineering team built. You have an exploratory mindset and can collaborate with cross functional teams.
You will:
- Participate in agile teams to test complex solutions
- Execute test cases manually and using automation scripts
- Develop automation scripts where possible to streamline the execution of tests and ensure repeatability
- Work with engineering to determine regression testing needed for software changes
- Review functional and design requirements to identify gaps and determine test strategies
- Analyze business scenarios, develop excellent test scripts and work independently (hands-on)
- Identify defects and improve quality
- Deliver high quality software in a timeframe that matches business needs.
- Follow processes by adhering to documented methodology. Provide good and clear test cases, with traceability to requirements and defects
- Work closely with cross functional teams, including Developers, Product Managers, DevOps, etc in an Agile fast-paced environment
- Ensure that all assigned project deliverables meet the quality objectives in functionality, usability, integration, regression, performance, stability, security and compliance
Your Qualifications:
- Relevant QA Engineering experience
- Strong written and verbal communication
- Proven ability to troubleshoot, review logs and identify issues
- Ability to understand technical specifications and analyze log files
- Knowledge of professional software engineering best practices for the full software development life cycle
- Familiar with object-oriented programming and scripting languages like Java, Javascript, Python, etc
- Knowledge of software standards such as IEC 62304 is a plus
To apply: please forward your resume to talent@medcrypt.co and be sure to include the role in the subject line
Senior Deputy Director, Cybersecurity Quality & Safety- $200k
The Role As the Senior Deputy Director, Cybersecurity Quality and Safety, you will be helping the Senior Director to lead MedCrypt’s Regulatory Services team. In your role, you will help medical device manufacturers (MDMs) understand how to meet cybersecurity regulatory requirements. You will evaluate medical device manufacturers’ cybersecurity designs and regulatory documentation to demonstrate secure, safe and effective devices. The Senior Deputy Director, Cybersecurity Quality and Safety will help lead a team of regulatory specialists and analysts to perform gap analyses, documentation review, architecture analyses and cybersecurity design assessments.
Duties & responsibilities
- Manage projects and staff allocations to ensure success for clients and growth opportunities for team members
- Capture new client opportunities by rapidly converging on the project needs, identifying the true objectives, and determining the appropriate resources to complete successfully
- Aid in marketing our services by Informing potential customers, helping clients develop a sense urgency to act
- Earn trust with clients, and deliver creative or innovative solutions to achieve the clients’ objectives
- Review FDA submission documents related to device indications for use (IFU), device architecture, and cybersecurity
- Engage in tabletop exercises and workshops to resolve documentation and/or design gaps, working collaboratively with the client
- Identify and troubleshoot design gaps in cybersecurity architecture for medical devices when evaluated against best practices/FDA guidance/FDA requirements (per Appropriations Bill)/international standards
Qualifications
- Strong experience working in regulatory affairs or cybersecurity at an MDM, or similar
- Excellent written communication skills, critical thinking, and ability to craft documents that clearly communicate to regulatory authorities
- Familiarity with FDA guidance documents and/or international cybersecurity standards
- Ability to learn/use a wide variety of tools for project management, data capture and analysis
- Strong bias for action and ownership
Bonus
- Previous exposure to FDA (either at FDA, or engaging with FDA through pre-submissions or premarket filings)
- Certifications in cybersecurity domains (CISSP or similar) or background in data privacy in healthcare (HIPAA)
How to Apply
Please submit your resume to talent@medcrypt.co, be sure to include the title of the role in the subject line.
VP Services- $200k
The Role: As the Vice President of Services, you will be responsible for leading and managing the Services division of our organization. You will play a critical role in developing and executing our cybersecurity services strategy, ensuring the delivery of high-quality services to our clients, and driving the growth and success of our client offerings.
Core Accountabilities:
- Leadership and Strategy: Develop and execute a comprehensive services strategy aligned with the organization's overall goals and objectives.
- Service Delivery and Operations: Oversee the delivery of cybersecurity services to clients, ensuring high-quality and timely delivery that meets or exceeds client expectations.
- Client Relationship Management: Establish and maintain strong relationships with key clients, acting as a trusted advisor on cybersecurity matters.
- Team Development and Talent Management: Recruit, develop, and retain top cybersecurity talent, fostering a culture of excellence, collaboration, and continuous learning.
Duties & Responsibilities:
- Provide strategic guidance and thought leadership to drive the growth and profitability of the Services division.
- Collaborate with senior leadership to align Services with business objectives and market trends.
- Stay updated on the latest cybersecurity threats, technologies, and best practices to drive innovation and maintain a competitive edge.
- Build and manage a high-performing team of service delivery managers, consultants, analysts, and engineers.
- Define and implement operational processes and procedures to ensure efficient service delivery, resource allocation, and client satisfaction.
- Monitor service performance metrics, analyze trends, and implement continuous improvement initiatives to enhance service quality and efficiency.
- Collaborate with sales and business development teams to identify and pursue new business opportunities, expand client relationships, and achieve revenue targets.
- Conduct regular client reviews to assess satisfaction, identify opportunities for improvement, and address any concerns or issues.
- Provide mentorship, coaching, and professional development opportunities to enhance the skills and capabilities of the Services team.
- Develop career paths and succession plans for key roles within the division, ensuring a strong talent pipeline.
- Collaborate with the legal and compliance teams to ensure that cybersecurity services adhere to relevant laws, regulations, and industry standards.
- Identify and manage cybersecurity risks associated with service delivery and operations, implementing appropriate controls and mitigation strategies.
Qualifications and Experience:
- Bachelor's degree in a related field; advanced degree preferred.
- Extensive experience in cybersecurity services, with a strong background in consulting, risk assessment, incident response, and/or security operations.
- Proven track record of successfully leading and growing a cybersecurity services practice.
- In-depth knowledge of cybersecurity principles, frameworks, technologies, and industry trends.
- Strong business acumen and ability to align cybersecurity services with organizational goals.
- Excellent leadership and people management skills, with the ability to build and motivate high-performing teams.
- Strong client relationship management skills and the ability to drive business development efforts.
- Exceptional communication and presentation skills, with the ability to effectively communicate complex cybersecurity concepts to both technical and non-technical stakeholders.
To apply: please email your resume to talent@medcrypt.co being sure to include the role in the subject line
Is your perfect position not listed here?
Send us an email at talent@medcrypt.com and we will try to find a perfect role for you!
We live and breathe healthcare cybersecurity
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