Senior Manufacturing Engineer (781064)

Drive product and process improvements in support of Insulet’s Operations (3) main objectives: Best Quality, Highest Efficiency, and Lowest cost. Project deliverables for installation of new manufacturing equipment and manufacturing equipment upgrades. Support equipment validation and continuous improvement activities at Insulet manufacturing facilities. Support 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 and own the required efforts to ensure these KPIs are at or above target. Develop and drive Continuous improvement efforts. Generate validation and qualification (IQ, OQ, PQ) protocols, coordinate the execution of the validation and qualification protocols and write validation and qualification final reports. Use standardized root cause investigation templates and problem-solving tools to carry out non-conforming material investigations. Implement corrective and preventive actions. Support new product introduction initiatives. Carry out duties in a quality system environment. At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing. Author and implement Engineering Change Orders. Position is fixed location based in Acton office; however, telecommuting from a home office may also be allowed.

Requires a Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or Electrical Engineering or a directly related field plus five (5) years of medical device experience.

Must have one (1) year of experience in each of the following (experience may be gained concurrently):

- Semi or full automated manufacturing environment

- Using data-driven methodologies including PDCA, A3, and 8D to resolve quality issues and to lead continuous improvement projects

- Monitoring and reporting on yield and equipment up-time information, including owning the required efforts to ensure these KPIs are at or above target

- Creating and revising key manufacturing-related risk documents, including Process FMEAs, manufacturing line specifications, and equipment specifications

- Identifying of root causes for operational failures using problem-solving tools such as Fishbone diagrams, 5 Whys, or Pareto charts

- Supporting new product introduction initiatives

- Leading Corrective and Preventive Action (CAPA) initiatives

- Using Data Analysis Skills using Minitab or JMP

- Assembly of molded components and identifying equipment problem areas and proposing solutions

- Implementing changes per ISO 13485

- Planning and executing Test method validation (TMV) on vision systems

- Executing process validation protocols (IQ/OQ/PQ)

Will accept a Master’s degree plus two (2) years of medical device experience and all above skills in lieu of a Bachelor’s degree plus five (5) years of experience and all above skills.

Please copy and paste your resume in the email body (do not send attachments, we cannot open them) and email it to candidates at placementservicesusa.com with reference #781064 in the subject line.

Thank you.