Principal Design Quality Engineer

This position is considered a subject matter expert in all aspects of new product development (NPD) while applying comprehensive knowledge of quality engineering principles, risk management and design for manufacturability (DFM) to ensure the highest level of quality in new products, and their compliance to applicable regulatory standards. This individual will serve as the central point of contact for R&D and Manufacturing teams.Responsibilities

• Lead Design Quality Engineering on cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, R&D, Regulatory Affairs, Operations/ Planning, and Marketing.
• Apply comprehensive knowledge of Design Control principles and Quality Engineering to positively influence new product development efforts.
• Ensure product compliance to regulations, standards, and quality system by driving functional excellence in Design Assurance and championing activities to implement changes and improvements.
• Recommend test methods and identify statistical methods for achieving required level of product quality and reliability.
• Proactively identify opportunities for improvements in areas of system compliance and product development.
• Provide oversight as necessary for the improvement of quality programs, systems, processes, and procedures to align with future business needs regarding NPD strategies.
• Partner with key suppliers to ensure product quality and test methods meet Inari’s quality standards for NPD.
• Drive compliance in all aspects of risk management and usability engineering activities throughout the product life cycle.
• Mentor and teach junior team members; standardize best practices.
• Define best practices for product development and sustaining commercial
• products.
• Provide expertise and guidance, within the scope of quality system, to ensure compliance within designated projects and product lines.
• Work closely with other cross-functional groups to achieve project goals.
• Perform special projects as assigned.

Qualifications

• Bachelor’s degree in Engineering or Technical field.
• Thorough knowledge of medical device regulatory laws and standards.
• Highly experienced in medical device Design Quality and Risk Management.
• Working knowledge of advanced statistics and problem-solving techniques.
• Over 7 years of experience in a design quality engineering role in medical devices.
• Excellent verbal and written communication skills.
• Detail oriented; deliver high quality product consistently and on time.
• Ability to navigate a fast-paced and dynamic work environment.
• Hands-on problem-solving abilities.
• Drive cross-functional buy-in prior to skillful execution of tasks or projects.
• Computer skills including statistical/data analysis and report writing skills.

Preferred

• Certification in Six Sigma Black Belt / ASQ certification preferred.
• Medical device product launch experience (involvement from concept to launch) highly desirable.

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $115,000-$140,000. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.