FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and maintaining risk management strategies, ensuring compliance with FDA regulations and ISO standards, and leading cross-functional teams in quality system processes. Proficient in conducting risk analyses, managing product lifecycle documentation, and implementing effective risk controls.
Highest-signal resume keywords
Risk Management StrategiesFDA Regulations ComplianceDesign Failure Modes And Effects Analysis (DFMEA)Root Cause AnalysisQuality Management Systems
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Risk ManagementStatistical ProcessesRegulatory ComplianceTest Plans DevelopmentRisk EvaluationDesign ValidationDesign VerificationPost-Market SurveillanceProcess FMEAUser FMEA
Soft Skills
Analytical SkillsProblem-Solving SkillsLeadership SkillsProject Management SkillsCommunication Skills
Tools & Technologies
Requirements Management ToolQuality Management Systems
Industry Keywords
Medical Device IndustryISO 13485ISO 14971Regulated Engineering FieldHuman AnatomySurgical Procedures
About the role
Key responsibilities & impact- Develop and maintain comprehensive risk management strategies
- Collaborate cross-functionally to ensure product quality and patient safety
- Create and maintain risk management files, plans, and reports
- Conduct regular risk reviews
- Lead hazard and risk analysis activities and implement risk controls
- Lead Design Failure Modes and Effects Analyses (DFMEAs)
- Analyze and review product complaints
- Integrate product security measures and vulnerabilities into the risk management file
- Participate in Process FMEA/User FMEA development
- Lead design reviews and maintain the risk management file throughout the product lifecycle
- Develop and manage post-market surveillance plans
- Lead field issue evaluations, including root cause analysis, risk evaluation, and product containment strategies
- Ensure traceability between risk files, requirements, and design outputs using a requirements management tool
- Evaluate safety risk implications of design changes
- Lead and mentor teams in quality-system process development and maintenance
- Define and implement engineering and statistical processes with cross-functional teams
- Ensure compliance with FDA, ISO, and international regulatory standards
- Participate in regulatory audits and inspections
- Oversee design validation and verification activities
- Develop test plans, protocols, test methods, and reports
- Ensure accurate documentation of test results, risk assessments, and reports
Requirements
What you’ll need- Minimum bachelor’s degree in engineering or a related technical field
- In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards
- Strong analytical and problem-solving skills, including thorough root cause analysis
- Excellent written and verbal communication skills
- Proven leadership and project management skills
- Ability to lead teams and manage multiple projects simultaneously
- Regulated engineering field experience
- Medical device industry experience
- Proficiency in quality management systems, risk management, regulatory compliance, and statistics
- Basic knowledge of human anatomy/physiology and surgical procedures
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
- For baccalaureate degrees earned outside the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Benefits
Comp & perks- Competitive salary and flexible benefits package
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account
- Healthcare 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-qualified Retirement Plan Supplement
- Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums
- Temporary employees: paid sick time as required by applicable state law
- Temporary employees: Employee Stock Purchase Plan