60 Insulet Principal Systems Engineer Jobs Hiring Near You

Job Summary

Updated Job Description sent by Dan Silva. SMF 3/22/2023
Job Title: Senior Manufacturing Engineer
FLAS Status: Exempt
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 Quality
Highest Efficiency
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; 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
Up to 5% travel required, ability to travel internationally
Performs other duties as required
Skills/Competencies:
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
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.
Physical Requirements:
Able to work in Class 8 Cleanroom Environment for extended time in a standing position
Education and Experience:
BS. in Mechanical/Industrial/Electrical Engineering and 6+ years of medical device experience; preferably in a manufacturing environment
MS. in Mechanical/Industrial/Electrical or Engineering Management with 5+ years of medical device experience; preferably in a manufacturing environment
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Position Summary
The Sr. Manufacturing Engineer, Global Engineering, will be a key team member in the growth and ongoing support of Insulet's manufacturing base across the world, at Contract Manufacturer (CM) sites and at Insulet's US Manufacturing facility in Acton, MA.
The candidate will be based out of Insulet HQ in Acton, MA, but will be expected to travel frequently to manufacturing sites as required to complete project deliverables. This candidate will be 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 use his/her 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 manufacturing equipment and processes. The person 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 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
Project deliverables for installation of new manufacturing equipment
Management of capital equipment projects including coordination with suppliers to ensure performance, timing and budget targets are met
Support equipment validation and continuous improvement activities at CM and at Insulet manufacturing facility
Drive product and process improvements in support of Insulet's Operations (3) main objectives
oBest Quality
oHighest Efficiency
oLowest cost
Develop and drive Continuous improvement efforts.
At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.
Generate validation/qualification (OQ, TMV, CSV, PQ) 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
Up to 50% travel required, mostly international (China, Canada)
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
Education and Experience
Education and Experience:
Minimum Requirements:
S. in Mechanical Engineering and 6+ years of medical device experience
S. in Mechanical/Industrial or Engineering Management with 5+ years of experience
Preferred Skills and Competencies:
Proficient in all Microsoft Office tools
Excellent Microsoft Excel and Data Analysis Skills - Minitab of JMP
Proficient in Solidworks and drafting skills
Understanding of Six Sigma/Lean manufacturing concepts
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
Physical Requirements (if applicable):
List physical requirements of role if any (standing, sitting, etc.) and/or travel requirements
Travel Requirements (if applicable):
upwards of 75% travel in China

Job Title: Senior Manufacturing Engineer (On-site)

FLAS Status: Exempt

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 Quality
• Highest Efficiency
• 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; 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
• Up to 5% travel required, ability to travel internationally
• Performs other duties as required

Skills/Competencies:

• 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

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.

Physical Requirements:

• Able to work in Class 8 Cleanroom Environment for extended time in a standing position

Education and Experience:

• BS. in Mechanical/Industrial/Electrical Engineering and 6+ years of medical device experience; preferably in a manufacturing environment
• MS. in Mechanical/Industrial/Electrical or Engineering Management with 5+ years of medical device experience; preferabl...