Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Position Overview:   

The candidate will work both on the addition of new manufacturing lines and equipment, as well as continuous improvement efforts for existing manufacturing processes/equipment.

The candidate will build and apply knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful validation and performance of new and existing manufacturing equipment and processes.

The candidate will be responsible for KPIs for project budget and timing, as well as machine up-time, process yield and efficiency once equipment is in production.

As part of providing support to the Global Manufacturing Engineering Group, the candidate will also carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work instructions, SOPs, non-conforming material investigations, and tool files. 

Responsibilities:

Drive product and process improvements in support of Insulet's Operations (3) main objectives;Best QualityHighest EfficiencyLowest cost

Project deliverables for installation of new manufacturing equipment and manufacturing equipment upgradesSupport equipment validation and continuous improvement activities at Insulet manufacturing facilitiesSupport responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above targetDevelop and drive Continuous improvement efforts.Generate validation/qualification (IQ, OQ, TMV, CSV, PQ) protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reportsPossesses strong mechanical analysis skillsAnalyze a product using mechanical engineering methods such as FBD analysis and fundamental physics.Use standardized root cause investigation templates and problem-solving tools to carry out non-conforming material investigationsImplement corrective and preventive actionsSupport new product introduction initiativesTravel to key suppliers to help them carry out critical investigations or improvement projectsCarry out duties in a quality system environmentAt all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.Author and implement Engineering Change OrdersUp to 5% travel required, ability to travel internationallyPerforms other duties as required

Skills/Competencies:

Proficient in all Microsoft Office toolsExcellent Microsoft Excel and Data Analysis SkillsWorking knowledge of Minitab and/or JMP statistical analysis softwareWorking Knowledge of Solidworks and print readingProficient in Six Sigma/Lean manufacturing conceptsComfortable troubleshooting mechanical equipment both Semi and fully automatedBasic knowledge of common challenges with assembly of molded components, stamped metal, and springsStrong command of structured problem-solving toolsStrong project management skills

Behavioral Competencies:

Decision Making – has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions.Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively.Work Organization – Takes a structured, economical approach to resources including time, people, money, and equipment.Problem Solving – Uses a systematic, methodical approach to gather facts, define problems, generate and implement solutions.Initiative – Makes decisions and takes actions appropriately.  Willing to take risks as circumstances require.Planning Skills – Sets goals and priorities, thinks ahead, identifies activities and resources needed to achieve goals.Perseverance – Achieves objectives by overcoming difficulties through tenacity and resilience.

Education and Experience:

BS. in Mechanical/Industrial/Electrical Engineering preferably in 6+ years of medical device experience (manufacturing environment)