- Title: Cyber Security Engineer
- Code: RCI-83112
- Posted Date: 06/20/2020
- Duration: 12 Months
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
Medical device expericence ideal looking for senior level. Day to day is cyber security procedures and updates on existing SOP DOP procedures. Technically - take care of assessments. Hard skills - expertise on cyber security and medical device are Mandatory! Quality experience is not mandatory but preferred. The cyber security is for product vascular.
- Lead vascular cybersecurity quality engineering activities by developing and maintaining cybersecurity policy, standards, applications, systems, etc.
- Develop a risk-based cybersecurity program which meets regulatory requirements and aligns with industry leading information security practices.
- Work closely with R&D software engineers on threat identification and mitigation activities using industry leading cybersecurity controls and tools sets.
- Collaborate with business units, application development teams, and third-party vendors to achieve program requirements while enabling the business.
- Facilitate cross team coordination to achieve defined cybersecurity goals as well as meet technical requirements in support of detailed implementation plans for cybersecurity projects.
- Prepares overall project quality plans including milestones, validation processes and documentation procedures.
- Conducts special analyses and projects as required.
- Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
- Responsible for problem resolution, communication and policy implementation.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- A Bachelor's degree in an applicable engineering discipline with ten (10) plus years of progressively more responsible work experience in quality assurance and design related to medical devices, preferably in electro-mechanical and implantable medical devices (class III and IV).
- Broad cross-disciplinary and in-depth knowledge and experience with industry accepted quality assurance design methodologies and project management tools.
- Direct cybersecurity and product development experience.
- Five years or more in quality or R&D engineering management.
- Desired: An advanced credential in a relevant discipline/concentration. Professional certification or designation, such as CQE, CSQE, CRE and/or CMQ/OE.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a fast-paced changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multi-tasks, prioritizes and meets deadlines in timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Ability to maintain regular and predictable attendance.