Sr. Manufacturing Engineer – Gse

Sr. Manufacturing Engineer – Gse

Requirements

• Proficient in all Microsoft Office tools
• Excellent Microsoft Excel and Data Analysis Skills
• Working knowledge of Minitab and/or JMP statistical analysis software
• Working Knowledge of Solidworks and print reading
• Proficient in Six Sigma/Lean manufacturing concepts
• Comfortable troubleshooting mechanical equipment both Semi and fully automated
• Basic knowledge of common challenges with assembly of molded components, stamped metal, and springs
• Strong command of structured problem-solving tools
• Strong project management skills
• High School diploma and 10+ years of practical experience in Engineering within a highly regulated manufacturing environment; preferably in the medical device industry OR BS. in Mechanical/Industrial/Electrical Engineering and 6+ years of experience in a highly regulated manufacturing environment; preferably in the medical device industry OR MS. in Mechanical/Industrial/Electrical or Engineering Management with 5+ years of experience in a highly regulated manufacturing environment; preferably in the medical device industry.

Responsibilities

• Drive product and process improvements in support of Insulet’s Operations main objectives: Best Quality, Highest Efficiency, Lowest cost
• Manage 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; own the required efforts to ensure these KPIs are at or above target
• Develop 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 reports
• Possesses strong mechanical analysis skills
• Analyze 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 investigations
• Implement corrective and preventive actions
• Support new product introduction initiatives
• Travel to key suppliers to help them carry out critical investigations or improvement projects
• 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
• Performs other duties as required.

Preferred Qualifications

• 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