Associate Engineer, Maintenance Operations

Position Overview: • The Associate Engineer support equipment reliability, TPM implementation, maintenance excellence programs, technician competency development and process optimization initiatives across manufacturing operations. Serves as the focal person for Maintenance Academy, Engineering Transcript management, maintenance documentation governance, and TPM activities while supporting equipment performance improvement and manufacturing process optimization. The (AE) must be proficient in strong analytical, communication, and technical writing skills, as well as attention to detail and the ability to work with cross-functional teams.

 Responsibilities: Coordinate and maintain engineering transcript, competency, training governance, and qualification programs, including training records, competency assessments, and workforce development activities. Coordinate and maintain site Maintenance Academy program through training coordination, competency tracking, technician certification, and capability development initiatives. Support preventive maintenance excellence initiatives by maintaining maintenance standards, documentation governance, compliance requirements, and maintenance best practices. Participate in TPM and reliability improvement activities, including Autonomous Maintenance, Planned Maintenance optimization, predictive maintenance and continuous improvement programs. Participate in Lean Manufacturing, Six Sigma, Kaizen, and process optimization initiatives to improve operational performance and equipment effectiveness. Analyze maintenance and operational data to identify improvement opportunities and support corrective actions. Maintain engineering records, maintenance documentation, and change control records in accordance with company procedures. Collaborate with Production, Quality, Maintenance, and Engineering teams to support equipment reliability, process improvement, and operational excellence initiatives. Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485. Perform other duties as assigned.

Bachelor’s degree in engineering (e.g., Chemical, Mechanical, Electrical), Life Sciences, or a related field. Basic proficiency in MS Office (MS Word, Excel, Power Point, Outlook) and data analytics Tools. Exposure or academy education in data analysis tools such as DOE and process development. Exposure or academy education in structured problem-solving tools (e.g. DMAIC, Six Sigma, Black Belt). Exposure to manufacturing, maintenance, reliability, TPM, or process improvement activities in pharmaceutical, medical device, or related industries.

Preferred Skills and Competencies: Analyze data, identify issues or non-conformances, and recommend or implement corrective actions to improve process efficiency and product quality. The ability to analyze data using various operating systems and programs and to develop intra-department teams to establish goals and take corrective actions to improve performance. Collaborate with Production, Quality, Maintenance, and Engineering teams to support equipment reliability, maintenance excellence, and process improvement initiatives. A combination of education, training, and experience that results in demonstrated competency to perform the work may be substituted. Have strong interpersonal and communication skills. Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively. Planning Skills – Sets goals and priorities, thinks ahead, and identifies activities and resources needed to achieve goals.

Able to work off shifts (nights/weekends) as needed, 10% max. 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