Position Title: Senior SQA Engineer Department: Product Development
Reports To: Principal SQA Engineer/Tech Lead FLSA: exempt
GENERAL SUMMARY
Senior SQA Engineer is a senior-level position that involves the testing and verification of complex software solutions to ensure they meet quality standards. This role identifies software defects and contributes to the delivery of high-quality products that meet the needs of the intended use of our products as well as the quality and regulatory expectations for medical device development and production.
ESSENTIAL JOB FUNCTIONS
Participate in verification, testing, and documentation of medical device software per governing SOPsDocument verification procedures, verification results and traceability matrices.Develop solid understanding of the medical device software products Document testing methodologies, along with defect tracking and reporting.Create, execute, and maintain test scripts for use within projects and regression testing. Set up and maintain testing environments for different testing needsWork closely with the software engineering team in all phases of the development cycle.May work on automating verification procedures to achieve test automation of the medical device software productsMentor more junior SQA engineers and conduct technical training for the SQA engineering team. OTHER DUTIES AND RESPONSIBILITIESAdditional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise.Position Title: Technical Operations Support Intern Department: Operations
Reports To: Operations Manager FLSA: Non-exempt
GENERAL SUMMARY
Under limited supervision and general guidelines, the Technical Operations Support Intern will aid the Operations team across various tasks between the Service and Shipping & Receiving teams.
ESSENTIAL JOB FUNCTIONS
Generate and maintain test and device recordsPerform rework, testing and troubleshooting of failed or returned productsPerform maintenance of new productFollow ESD policy & practicesComplete receipts of returned products, including both medical devices and their accessories on their respective RMAs, Sales Orders, or Purchase Orders according to outline procedures.Prepare and complete shipments of products to end users according to outlined procedures.Perform duties in a safe, non-hazardous manner in compliance with safety standards within a timely fashion meeting production deadlinePerform individual tasks as assigned; establish and maintain effective, professional, and respectful work relationships within the department and corporate communityMaintain professional competence, knowledge, and skills necessary for the satisfactory performance of all assigned responsibilitiesGENERAL SUMMARY
The New Product Introduction (NPI) Engineer at Intuvie facilitates the transition of new products and product changes from the engineering team to the manufacturing team. Successful candidates possess a blend of technical and hands-on experience in medical device development and manufacturing. Experience with the detailed requirements of CGMP, familiarity with general product quality management, and manufacturing engineering and process development are important for this role. The NPI Engineer will be a key member of the engineering team, ensuring DFM during development while being responsible for technology transfer activities with internal teams and external manufacturing partners to transition products from development to full scale production. The job responsibilities are broad and require flexibility, attention to detail, and good organization skills.
ESSENTIAL JOB FUNCTIONS
Work with Engineering, Quality, and External Manufacturing teams to provide guidance on manufacturability, robustness, DFM, and process/supplier development during new product development and post market/sustaining support.Owndesign transfer activities to external manufacturing partnersfor both new productsand product changes. Activities could include, but not limited to: Cost analysis, processand equipment development,suppliercapabilitydevelopment, control of Manufacturing and Quality documentation. Leadthe Change Control process forproduct or process improvement projects.Create design transfer plans,schedules, and deliverables. Document project activities.Work closely with suppliers,purchasingand development to ensure designspecifications are adequately defined and met.Analyze and improve the effectiveness of current contract manufacturing processes.Analyze and improve the efficiency and quality of manufactured parts and sub-assemblies.Develop efficient process flow, manufacturing fixtures, and manufacturing work instructions in collaboration with contract manufacturers.DevelopDFMbest-practicesand guidelines.Assistin evaluating, resolving, and auditing quality issues.Provide guidance for Lean Manufacturing at Contract Manufacturer to reduce waste Initiate continuous improvement projects throughout the company. Oversee and Support Contract Manufacturer for the selection, installation, qualification (IQ/PQ/OQ) of tooling and/or capital equipment utilized in product manufacture. Provide progress reports to management as required.OTHER DUTIES AND RESPONSIBILITIES
May contribute directly to new product engineering or product design changes depending on resource availability.Review product designs for manufacture ability content.Develop Quality Management System procedures to refine the New Product Introduction/Design Transfer process.PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
Bachelor of Science inManufacturing, Mechanical or ElectricalEngineering or equivalentexperience.Five or more yearsinrelated work experience in a medical device environmentUnderstanding ofelements of design that impact product cost and quality. Ability to influence the cost and quality of new products early in the design process.Experience with the full development life cycle ofdurablemedical equipment and disposables. General understanding of all manufacturing operations within the company and at our contract manufacturers and their suppliersExcellent analytical, organizational, written, verbal communication, and hands-on skills.Works cooperatively with R&D, Quality and Regulatory, Production Facilities, Supply Chain, and Marketing on complex projects to ensure project successProficient in Computer Aided Design software such as SolidWorksExperience with statistical methods. Six-Sigma Green Belt isa plus.Able to prioritize and take initiative with minimal guidanceAble to helpfacilitateactions and work with others across multiple departments and organizations Strong problem-solving skillsSelf-motivatedAbility to work effectivelyto meet deadlinesSolid organizational skills-able to handle multiple tasks simultaneouslyWorking knowledge of Microsoft applications including MS ProjectFluency in Mandarin is a plus Read Less