Product Quality Engineer 2
$78,000–$122,100 year
On-siteNewark, Delaware, United States
Newark, Delaware, United StatesOn-siteFull Time$78,000–$122,100 yearBachelors DegreeHealthcare TechLarge
Full TimeBachelors DegreeLargeHealthcare Tech
Job Summary
Conduct post-market investigations, risk assessments, and root cause analysis for medical devices based on field complaints. Lead cross-functional teams in implementing design or process changes, including drawing updates, tooling modifications, and change control documentation. Execute health risk assessments, perform data trending to identify threshold risks, and present findings to internal stakeholders and leadership. Partner with field-based teams to resolve quality issues at customer sites while preparing materials for Quality Investigation Review boards and audits.
Required Qualifications
- Bachelor's Degree in Engineering (Mechanical, Electrical or Biomedical)
- Bachelor's degree in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering
- 2-5 years experience
- Experience in an FDA regulated industry
- Working knowledge of FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP
- Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
- Ability to appropriately assess written product and project documentation as an advocate for compliance, and ability to effectively communicate assessment
- Knowledge of root cause analysis tools and ability to lead root cause activities for complaint investigations, NCs, CAPAs, etc.
- Good communication and presentation skills
- Works with intermediate level of autonomy and independence, requiring minor oversight on complex problems with analysis requiring a variety of factors
Desired Qualifications
- Experience in root cause analysis or product development/R&D is beneficial
- Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment
- Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements
- Working knowledge of verification and validation requirements for a regulated product
- Familiarity with requirements analysis, including development of testable and measurable specifications
- Knowledge of risk based and statistical analysis concepts
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