Lead planning and execution of the new product development and design change projects with focus on Design Controls and Risk Management activities.
Work effectively with cross-functional teams for the harmonization and consistency across several projects.
Take ownership of the processes (Design Controls and Risk Management).
Identify improvement opportunities, lead cross functional teams to implement the process improvements.
Provide mentorship, guidance and training to the product development teams new.
Support the implementation of eQMS tools for design controls and risk management (eDHF).
Lead Design Reviews with participation from the core teams.
Provide review and approvals of DHF deliverables such as verification and validation plan, protocol/report, requirements, and specifications.
Lead creation of risk management file with support from the cross-functional product development teams, risk management plan/report, hazard analysis, dFMEA, uFMEA.
Maintain risk file in the post market lifecycle phase.
Support design transfer activities including BOM and DMR.
Assist in regulatory inspection readiness activities and provide support during regulatory site inspections.
Participate in process improvement initiatives as necessary, performing gap analysis.
Perform root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to design controls and risk management.

Minimum 10+ years of hands-on experience, or relevant comparable background.
Advanced understanding of the ISO 13485, FDA QSR/21 CFR Part 820, ISO 14971.
Basic understanding of the IEC 62304, 62366 standards.
Technical expertise and understanding of IVD assays and data analysis tools.
Experience in successfully leading new product development teams through design controls and risk management processes, including DHF documentation including product risk file.
Requires strong oral and written communication skills and interpersonal skills.
Experience with IVDR, CAP/CLIA and GCP/GCLP preferred.
Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.
Experience with mentoring junior people on the team.
Adaptable to fast-paced, dynamic work environment with shifting demands.

Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions ) and reference verification.
Employees may be required to lift routine office supplies and use standard office equipment.
Ability to sit for extended periods of time.
Most work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes, and bio-hazardous material in the lab environment.
Travel may be required up to 15% of the time.
Job may require after-hours response to emergency issues. At times may be required to work weekends/holidays.

Senior Staff Design Quality Engineer

Key skills