Manager, Manufacturing Engineering

Insulet Corporation•Acton, MA

3d•Onsite

About The Position

The Manager, Manufacturing Engineering is a critical lead member of the Global Manufacturing Engineering team supporting the day to day activities of the Operations and Manufacturing Engineering Group. This leader is the owner of key automation equipment used to produce Insulet products. The individual will have around 6-8 Manufacturing Engineers reporting to them. This leader is responsible for KPIs for machine up time, process yield and efficiency for his/her group of automation equipment, in addition to managing and executing other manufacturing projects. Projects may include cost and quality improvements, line qualifications, new product introductions (NPI) and other as assigned by manager. As part of providing support to the Operations and Manufacturing 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.

Requirements

B.S. in Mechanical Engineering and 10+ years of medical device, or similar, experience
M.S. in Mechanical/Industrial or Engineering Management with 8 plus years of experience
Minimum of one year of experience leading and managing employees
Team Development: Build capability through coaching and mentoring.
Strategic Thinking: Align engineering priorities with business objectives.
Influence & Collaboration: Drive cross-functional improvements and resolve conflicts constructively.
Accountability: Set clear expectations and deliver results.
Change Leadership: Champion continuous improvement and adaptability.

Nice To Haves

Proficient in all Microsoft Office tools
Excellent Microsoft Excel and Data Analysis Skills – Minitab of JMP
Proficient in Solidworks and drafting skills
Comfortable troubleshooting mechanical equipment both Semi and fully automated
Basic knowledge of common challenges with assembly of molded components required
Strong command of structured problem solving tools
Excellent project management skills
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.

Responsibilities

Manager of Manufacturing Engineers responsible for performance and sustainability of automation equipment
All reporting / performance tracking requirements for their respective Cells
Drive product and process improvements in support of Insulet’s Operations (4) main objectives Best Quality Highest Efficiency Highest Customer Service Lowest cost
Develop and drive Continuous improvement efforts.
Manage Insulet Automation suppliers and deliver new machines and machine improvements
At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.
Generate validation/qualification protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports
Author and implement Engineering Change Orders
Design and coordinate the construction and validation of manufacturing fixtures
Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.
Use standardized root cause investigation templates and problem solving tools to carry out non-conforming material investigations
Implement corrective and preventive actions
Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target
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
Possesses strong mechanical analysis skills
Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics.
Interpret the mechanical properties of the selected material for the product design and make recommendations for suitable alternatives.
Performs other duties as required