What are the responsibilities and job description for the Sr. Manufacturing Engineer II position at Open Systems Inc.?
Fort Wayne, IN
Fulltime
The client produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer's quality specifications for each product we produce.
We are searching for a Sr. Manufacturing Engineer II to join our team that will be responsible for the follwoing: develop, establish and maintains engineering methods and systems to meet site specific, customer and regulatory requirements. Actively communicate initiatives to support departmental, plant and corporate operational goals. Serve as an engineering representative to provide support and guidance for new product transfers through volume production internally, at suppliers, and at customer locations. Drive new product introductions to meet customer specifications and delivery expectations.
What You'll Do
Works with representatives from customer service, manufacturing, quality assurance, scheduling, and purchasing in developing and coordinating new project development, sustaining products, suppliers, and internal operations.
Act as customer liaison on new and legacy projects
Create project quotes
Create costing of product
Apply margins in adherence to corporate goals
New Projects
Act as project manager for new projects to ensure quality and on time delivery
Initiate and coordinate preproduction meetings w/ customers and internally.
Create device master record (DMR) / processes that meet and/or exceed product, Avalign, ISO, FDA, and customer specifications and requirements
Perform design for Manufacturing/Cost/Quality - Technically support customer to eliminate costs and maximize delivery of product.
Post Productions Initiate and complete
NCMR disposition of product to meet Avalign and customer specifications
Continuous improvements in all areas of the facility
Support quality, operations, and purchasing groups
Decision making supportive of Corporate goals
Collaboration with internal and external customers to lead the process development and launch of new and revised products
Leads new projects from development through delivery with responsibility for providing reliable quality, cost, and delivery
Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material disposition and ECO implementation
Provide product and process DFx (Manufacturing, Assembly, Inspection) input to enhance manufacturability of new products
Uses statistical and financial analysis to identify trends and opportunities to systematically improve quality, reduce cost, reduce lead time, and reduce scrap
Applies advanced troubleshooting and root cause analysis methods to solve problems with documented results
Generates quotations for new and revised business
This position may have leadership responsibilities as assigned
What You Won't Do
Feel stuck we offer great opportunities to advance and learn
Get bored we make custom products, so no day is the same
Feel like a number we're a close-knit bunch and always have each other's backs
Who You Are
A self-starter who thrives in a fast-paced environment
A quick learner who is always ready to gain depth of knowledge in manufacturing processes
A reliable worker who knows the importance of showing up when it counts
Accept assignments with open, cooperative, positive and team-oriented attitudes
Able to plan and execute plans across teams
Effective communicator, both written and verbal
What You'll Need
Candidates should have a BS in an engineering science plus 7 years of manufacturing experience, or an equivalent combination of education and experience
New production introduction/process development experience in a manufacturing environment highly preferred.
Strong background demonstrating proficiency with problem solving and root cause analysis tools
Demonstrate ownership of and ability to manage project assignments with a broad scope and able to prioritize and complete work in a timely manner
Must have the ability to effectively work and communicate within a team and cross functionally to expedite completion of critical project tasks
Solid understanding and ability to lead Lean or TOC improvement initiatives
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred
Excellent customer service skills via written and verbal communication required
Strong computer skills (Microsoft Office, Outlook, etc.)
Modeling/drafting experience with Solidworks or similar CAD systems
Working knowledge of drafting standards and geometric dimensioning and tolerancing
Familiarity with MasterCam, Esprit, Partmaker, or similar CAM systems is a plus
What You'll Enjoy
Competitive compensation and benefits package
Comprehensive medical, dental, and vision insurance
Paid vacation and 10 observed paid holidays per year
Employer funded Basic Life and AD&D insurance
Employer funded STD and LTD insurance
Tuition reimbursement
Great 401(k) with company match
Generous employee referral bonus program
Working for a thriving, performance-based company that values promoting from within and career advancement
Temperature controlled environment
Community involvement investing and giving back to the community
Additional free resources such as travel assistance, EAP, etc.
Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Fulltime
The client produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer's quality specifications for each product we produce.
We are searching for a Sr. Manufacturing Engineer II to join our team that will be responsible for the follwoing: develop, establish and maintains engineering methods and systems to meet site specific, customer and regulatory requirements. Actively communicate initiatives to support departmental, plant and corporate operational goals. Serve as an engineering representative to provide support and guidance for new product transfers through volume production internally, at suppliers, and at customer locations. Drive new product introductions to meet customer specifications and delivery expectations.
What You'll Do
Works with representatives from customer service, manufacturing, quality assurance, scheduling, and purchasing in developing and coordinating new project development, sustaining products, suppliers, and internal operations.
Act as customer liaison on new and legacy projects
Create project quotes
Create costing of product
Apply margins in adherence to corporate goals
New Projects
Act as project manager for new projects to ensure quality and on time delivery
Initiate and coordinate preproduction meetings w/ customers and internally.
Create device master record (DMR) / processes that meet and/or exceed product, Avalign, ISO, FDA, and customer specifications and requirements
Perform design for Manufacturing/Cost/Quality - Technically support customer to eliminate costs and maximize delivery of product.
Post Productions Initiate and complete
NCMR disposition of product to meet Avalign and customer specifications
Continuous improvements in all areas of the facility
Support quality, operations, and purchasing groups
Decision making supportive of Corporate goals
Collaboration with internal and external customers to lead the process development and launch of new and revised products
Leads new projects from development through delivery with responsibility for providing reliable quality, cost, and delivery
Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material disposition and ECO implementation
Provide product and process DFx (Manufacturing, Assembly, Inspection) input to enhance manufacturability of new products
Uses statistical and financial analysis to identify trends and opportunities to systematically improve quality, reduce cost, reduce lead time, and reduce scrap
Applies advanced troubleshooting and root cause analysis methods to solve problems with documented results
Generates quotations for new and revised business
This position may have leadership responsibilities as assigned
What You Won't Do
Feel stuck we offer great opportunities to advance and learn
Get bored we make custom products, so no day is the same
Feel like a number we're a close-knit bunch and always have each other's backs
Who You Are
A self-starter who thrives in a fast-paced environment
A quick learner who is always ready to gain depth of knowledge in manufacturing processes
A reliable worker who knows the importance of showing up when it counts
Accept assignments with open, cooperative, positive and team-oriented attitudes
Able to plan and execute plans across teams
Effective communicator, both written and verbal
What You'll Need
Candidates should have a BS in an engineering science plus 7 years of manufacturing experience, or an equivalent combination of education and experience
New production introduction/process development experience in a manufacturing environment highly preferred.
Strong background demonstrating proficiency with problem solving and root cause analysis tools
Demonstrate ownership of and ability to manage project assignments with a broad scope and able to prioritize and complete work in a timely manner
Must have the ability to effectively work and communicate within a team and cross functionally to expedite completion of critical project tasks
Solid understanding and ability to lead Lean or TOC improvement initiatives
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred
Excellent customer service skills via written and verbal communication required
Strong computer skills (Microsoft Office, Outlook, etc.)
Modeling/drafting experience with Solidworks or similar CAD systems
Working knowledge of drafting standards and geometric dimensioning and tolerancing
Familiarity with MasterCam, Esprit, Partmaker, or similar CAM systems is a plus
What You'll Enjoy
Competitive compensation and benefits package
Comprehensive medical, dental, and vision insurance
Paid vacation and 10 observed paid holidays per year
Employer funded Basic Life and AD&D insurance
Employer funded STD and LTD insurance
Tuition reimbursement
Great 401(k) with company match
Generous employee referral bonus program
Working for a thriving, performance-based company that values promoting from within and career advancement
Temperature controlled environment
Community involvement investing and giving back to the community
Additional free resources such as travel assistance, EAP, etc.
Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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