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.
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 FMEA activities with project teams
- Analyze and review product complaints
- Integrate product security measures and vulnerabilities into the risk management file
- Participate in Process FMEA/User FMEA development and integration
- Lead design reviews and maintain risk management files throughout the product lifecycle
- Develop and manage post-market surveillance plans
- Lead field issue evaluation, root cause analysis, risk evaluation, and product containment during initial launch
- Ensure traceability among risk management files, requirements, and design outputs using a requirements management tool
- Evaluate safety risk implications of design changes
- Lead and mentor teams implementing and maintaining quality-system processes and standards
- Define and implement engineering and statistical processes with cross-functional teams
- Ensure compliance with FDA, ISO, and international standards
- Participate in regulatory audits and inspections
- Oversee design validation and verification activities, including test plans, protocols, 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
- Advanced degree preferred
- In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards
- Strong analytical and problem-solving skills
- Ability to conduct thorough root cause analysis
- Excellent written and verbal communication skills
- Ability to collaborate with cross-functional teams and present complex information to stakeholders
- Proven leadership and project management skills
- Ability to lead teams and manage multiple projects simultaneously
- Experience in a regulated engineering field preferred
- Medical device industry experience preferred
- Proficiency in quality management systems, risk management, regulatory compliance, and statistics
- Basic knowledge of human anatomy/physiology and surgical procedures
- CQE, Six Sigma Green Belt, or equivalent certification preferred
- AAMI design control certification preferred
- Unrestricted U.S. work authorization required at hire and throughout employment; sponsorship is unavailable below Principal level
- 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 eligible for paid sick time as required by applicable state law
- Employee Stock Purchase Plan for temporary employees
- Minimum four days per week onsite with in-person collaboration