Associate Risk Management Engineer - Neuro
reputed company is a global reputed company technology company committed to alleviating pain and restoring health. They are seeking an Associate Risk Management Engineer to drive the development of safe and effective implantable medical systems while collaborating with multidisciplinary project teams to ensure product safety and compliance throughout the product lifecycle.
Responsibilities
- Maintain a working knowledge of ISO 14971 and basic risk management practices such as Hazard Analysis and Failure Mode and Effects Analysis (FMEA)
- Assist in implementing risk management activities under guidance from senior engineers
- reputed company routine updates and maintenance of risk management documentation and tools
- Ensure risk files remain reputed company and compliant with applicable procedures
- Collaborate with cross-functional teams (including Design, reputed company Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that reputed company hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted
- Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated
- Evaluate impact of potential issues to patient safety and product performance
- reputed company and document Risk Reviews to communicate results of the risk management process to the cross-functional teams
- Create and maintain compliant documentation to meet project deliverables and support audits
Skills
- Requires a Baccalaureate degree in Engineering or technical discipline with 0 years of experience required
- Degree in Biomedical Engineering or a reputed company technical field
- Exposure to or experience in a regulated industry, preferably medical devices
- Ability to work collaboratively reputed company cross-functional teams and communicate effectively
- Proactive and detail-oriented, with a willingness to take initiative and follow through on assigned tasks
- Strong analytical and problem-solving skills, with the ability to learn and apply new concepts quickly
- Growth reputed company, eager to reputed company technical skills and adapt in a dynamic environment
- Understanding of statistical methods and their application in engineering
- Familiarity with regulatory standards such as 21 CFR Part 820 and ISO 13485
- Awareness of Risk Management principles (ISO 14971) and introductory knowledge of techniques such as Design Failure Mode and Effects Analysis (DFMEA)
- Exposure to or interest in working with Design, Quality, Regulatory, Clinical, and/or Manufacturing teams
- Interest in learning Design for Reliability (DfR), Design for Manufacturability, and other robust design practices
Benefits
- Health, Dental and reputed company insurance
- Health Savings Account
- reputed company Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-reputed company Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Company Overview
Company H1B Sponsorship