Job ResponsibilitiesTechnical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance)Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices.The ability to create, support, review chemistry, manufacturing, and controls device submissionsParticipates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completedLeads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods)Leads component qualifications, design validation, design verification, drug stability and process validationLeads product investigationsAbility to make and present risked based decisionsAssess product changes against product designSupports translation of design inputs into manufacturing control plansDevelop and implement procedures to comply with corporate and industry standards.Coordinates and/or directs all aspects of product development activity related to a product lineLeads development of risk assessments and test methodsQuality engineering representation on Product Development and Design Review teamsPrepare and present project updates and technical discussionsParticipate in project planning, budgeting, scheduling, and trackingSupport internal and external supplier auditsProvide support to the regulatory department in writing technical submissionsComplies with company procedures and policies, government regulationsActively participates in training and providing input to training of employees on division procedures and policiesAbility to travel for business, project, and issues approximately up to 25% of time.Other duties and projects, as assignedRequired Education and ExperienceBS in Engineering, Biological Science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or BiochemistryMinimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industryExtensive proven understanding of design controls in development stagePharmaceutical or combination product experienceRequired QualificationsApply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)Ability to lead creation of risk management filesAbility to develop solutions with business impactAdvanced statistical and risk assessment techniquesWorking knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologiesAbility to make and present risk-based decisionsStrong interpersonal skillsAbility to analyze and optimize manufacturing and quality systemsProduct, design & prototypingAbility to create and provide trainingProblem solving abilityAbility to create, review and coordinate test protocols and reportsAbility to generate engineering proposalsOral and written presentation skillsAbility to lead cross functional teamsUnderstanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH GuidelinesSkills and CertificationsDrug Device delivery combination productsCompensationBase Salary - USD $110,000 to $115,000Full-timeBenefits - FullRelocation Assistance Available - Possible for ideal candidateCandidate Details8+ to 10 years experienceSeniority Level - Mid-SeniorMinimum Education - Bachelor's DegreeWillingness to Travel - OccasionallyIdeal Candidate8+ years experience in New Product Development of combination devices#J-18808-Ljbffr