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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in risk management strategies, including hazard analysis, compliance with FDA and ISO standards, and effective communication across cross-functional teams. Proficient in utilizing statistical analysis tools and methodologies to ensure product quality and patient safety throughout the product lifecycle.
Highest-signal resume keywords
Risk ManagementDesign Failure Modes and Effects Analysis (DFMEA)ISO 14971 ComplianceStatistical Analysis (Minitab)Certified Quality Engineer (CQE)
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 AnalysisPost-Market SurveillanceDesign ValidationDesign VerificationRequirements ManagementClinical Risk AssessmentQuality EngineeringNew Product Development (NPD)Engineering ProcessesStatistical Processes
Soft Skills
Strong Communication SkillsCollaborationProblem-Solving
Tools & Technologies
Microsoft Office (Excel, Word, PowerPoint)Requirements Management ToolStatistical Analysis Software
Certifications & Qualifications
Certified Quality Engineer (CQE)Six Sigma Green BeltAAMI Design Control Certification
Industry Keywords
Medical DevicesPharmaceuticalsRisk Management StandardsFDA ComplianceISO 13485IEC 62304Design for Six SigmaDesign for Reliability
About the role
Key responsibilities & impact- Develop and maintain comprehensive strategies for risk management activities
- Collaborate cross-functionally to ensure product quality and patient safety
- Create and maintain the risk management file, including plans and reports, and conduct regular risk reviews
- Lead hazard and risk analysis activities to identify potential risks and implement risk controls
- Lead Design Failure Modes and Effects Analyses (DFMEAs) with project teams
- Analyze and review product complaints to anticipate and prevent future issues
- Integrate product security measures addressing potential vulnerabilities into the risk management file
- Participate in Process FMEA/User FMEA development and integrate them into the risk management file
- Lead design reviews and maintain the risk management file throughout the product lifecycle
- Develop and manage post-market surveillance plans
- Lead field issue evaluation during initial launch, including root cause analysis, risk evaluation, and product containment strategy
- Ensure traceability between the risk management file, requirements, and design outputs using a requirements management tool
- Evaluate safety risk implications of design changes
- Define and implement engineering and statistical processes supporting product quality and compliance
- Ensure compliance with FDA, ISO 14971, ISO 13485, IEC 62304, FDA Part 820, and other international standards
- Participate in regulatory audits and inspections
- Oversee design validation and design verification activities, including test plans, protocols, test methods, and reports
- Ensure thorough and accurate documentation of test results, risk assessments, and reports
Requirements
What you’ll need- Bachelors degree in engineering or a related technical field
- Experience in medical devices, pharmaceuticals, or combination products
- Familiarity with medical device risk management standards, including ISO 14971 concepts
- Prior involvement in New Product Development (NPD) environments
- Background in Quality Engineering, Risk Management, R&D, Systems Engineering, or similar roles
- Clinical knowledge or experience supporting clinical risk assessment
- Experience using Minitab or other statistical analysis software
- Certification or experience with Design for Six Sigma / Design for Reliability methodologies
- Strong written, verbal, and digital communication skills
- Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)
- Certified Quality Engineer (CQE), Six Sigma Green Belt, or equivalent certification preferred
- AAMI design control certification preferred
- For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment; sponsorship is not offered for roles below Principal level
Benefits
Comp & perks- Competitive Salary and flexible Benefits Package
- Health, Dental and 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
- Temporary employees are eligible for paid sick time, as required under applicable state law
- Employee Stock Purchase Plan for temporary employees