Jobs via Dice ยท 3 days ago
Senior Staff Engineer, Design Quality
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$101K/yr - $165K/yr
6+ years expStryker - Inari Medical is hiring a Senior Staff Engineer, Design Quality in Irvine, California. In this role, you will partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes that support new product development projects, while leading risk management activities to ensure the highest level of product and process quality.
Computer Software
Responsibilities
Develop quality documentation to support new product development and regulatory submissions
Maintain and improve quality systems by identifying and correcting procedural deficiencies
Lead risk management activities and present final risk/benefit justifications to leadership
Help create, maintain, and manage risk files throughout the product lifecycle
Drive product and process design activities in cross-functional teams
Define and validate design verification and validation (V&V) test requirements and methods
Present product risks during design reviews and ensure mitigation through development
Support manufacturing process development and product design transfer to internal/external sites
Apply statistical analysis and problem-solving techniques to define acceptance criteria and resolve quality issues
Review and approve inspection plans, routers, and product drawings
Evaluate predicate devices and define critical quality attributes through risk analysis
Contribute to final V&V reports with statistically valid conclusions and graphical summaries
Support early market feedback collection and resolution of initial product concerns
Qualification
Required
Bachelor's degree in science, engineering or related discipline
6+ years' related experience required
Medical device industry experience required
Familiarity with New Product Development (NPD) processes and/or involvement in cross-functional activities supporting product development and commercialization
Preferred
MS, CQE, or CRE preferred
Six Sigma Green or Black belts are preferred
Experience with the medical device development lifecycle, including risk management and design/process verification and validation
Proficient in quality tools such as FMEA, GD&T, root cause analysis, and Poka-Yoke, as well as core quality concepts
Proficient in data analysis tools (e.g., Minitab) and interpreting CAD drawings to support design and process evaluations
Proven project management and cross-functional collaboration skills
Excellent communication, problem-solving, and analytical abilities
Benefits
Bonus eligible
Benefits
Company
Jobs via Dice
Welcome to Jobs via Dice, the go-to destination for discovering the tech jobs you want.
0-1 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase