JOB DUTIES: Work with Quality Engineering and other functional groups to develop, implement and scale up new products/process development activities of Class III medical devices. Lead the design, development and review of manufacturing process changes, product design improvements and the implementation of new products efforts with quality improvement opportunities for legacy products, continuous improvement, and customer satisfaction. Lead efficient transfer of new design from development to production by assessing supplier’s process capabilities and part qualification. Provide technical oversight in defining and conducting internal/external product and process validations and requirements, working closely with Product Development, Applied Research, and Manufacturing personnel as well as vendors. Write, perform, and/or review technical documents such as Validation Protocols, Test Procedures, and Test Reports. Write, review and/or approve process and product validation protocols and reports, equipment qualifications, document change orders applying APQP & PPAP to develop production and design standards. Develop and establish effective quality control and resolve product quality issues. Develop trend requirements to support the QA/QC department in the following areas: NCR, CAPA, and SPC processes for incoming inspection, process, and vendor operations. Evaluate data and identify trends in order to develop innovative solutions. Use statistical tools, such as Standard deviation, Control charts, Pareto charts, Histograms, Trend analysis, and Six sigma methodology, to analyze data, make acceptance decisions, and improve process. Provide technical support in areas including validation requirements, statistics, biocompatibility assessment, DFM, risk analysis, FMEA, root cause analysis, testing requirements and methods, quality equipment, specifications, vendor quality, among others, and coordinate with suppliers/vendors to review and mitigate any non-conformance product and hazardous situation. Conduct, document, and maintain risk analyses for all development products and comply with risk analysis, design control, and any other related procedures. Develop and manage equipment and facility (including clean room) requirements, design, maintenance, and validation programs. Ensure compliance with all Federal, State, local and company regulations, policies, and procedures. Initiate and investigate Corrective and Preventative Actions (CAPA) and assist in complaint analysis as appropriate. Train, coach, and guide lower-level employees on routine procedures. *Up to 10% local travel to CMOs (Contract Manufacturing Organizations) in Massachusetts and New Hampshire. **Hybrid Remote permitted within Massachusetts. JOB REQUIREMENTS: 1. U.S. Master’s degree or equivalent in Industrial/Manufacturing Engineering, or related discipline, plus 2 years in job offered or as Industrial / Manufacturing / Quality / Supplier Development Engineer or related occupation. 2. Must include experience with the following: • Manufacturing process validation and GMP; • Statistical tools: Standard deviation, Control charts, Pareto charts, Histograms, Trend analysis, and Six sigma methodology; • Structured manufacturing frameworks, including APQP & PPAP; • Drafting standard quality requirements; • DFM, risk analysis, FMEA, testing requirements and methods; • NCR, CAPA, and SPC processes; • Evaluating supplier technical capabilities; • Coordinating activities with internal departments and outside vendors/suppliers. 3. Good written/oral communication skills. Interested Applicants, Email Resume: Avedro Inc. Attn: K. Sauer/ Ref SQE [email protected] #GKOSUS