Senior Manufacturing Engineer
3 weeks ago
Summary
This role is responsible for all aspects, from planning to execution, of manufacturing the SecurAcath device, including managing suppliers, contract manufacturers, cleanroom operations, and working with engineering, operations, and quality.
This position is based in Plymouth, MN (on-site).
Responsibilities
- Manage manufacturing and process development of nitinol-based medical components
- Manage manufacturing and process development of plastic-based injection-molded medical devices (both insert molding including robotic handling and two-shot molding)
- Manage suppliers of materials, components, and devices for manufacturing SecurAcath
- Review and approve automation and injection molding design
- Review and approve IQ, OQ, PQ, and first article protocols and reports
- Review and approve process capability requirements and reports
- Lead analysis of nonconforming components through Nonconforming Material Reports, Material Review Board, and Corrective and Preventive Actions
- Implement plans to increase yield/ decrease scrap
- Implement plans to decrease Cost of Goods Sold
- Implement plans for increasing capacity and capabilities ahead of projected growth
- Implement plans for material, component or equipment obsolescence
- Facilitate supplier meetings; plan objectives, prepare agendas, facilitate discussion during meeting, and compiling minutes including actions and decisions
- Develop and present insightful executive summaries and supplier performance scorecards
- Provide technical support for receiving and inspecting components and packaging devices
- Support internal product development projects including line extensions and next generation devices
- Substantially contribute to risk analysis, risk-based decision making and risk management
- Actual duties may include, but are not limited to, the preceding duties
Qualifications
- Bachelor’s degree in mechanical engineering or materials science or equivalent is required
- Ten years of medical device engineering experience required (vascular access and catheter experience preferred)
- Significant experience working with suppliers and contract manufacturers for new product introductions and transfers
- Significant experience designing and manufacturing nitinol-based medical components AND/OR injection-molded plastic-based medical devices required (multishot and insert molding preferred)
- 3D CAD and PDM software (SolidWorks preferred)
- Data analysis and statistical software (Minitab preferred)
- Experience with clean room equipment and processes for manufacturing
- Familiar with automated, electrical, optical, pneumatic, or robotic equipment for manufacturing
- Familiar with measurement systems (SmartScope and Measure-X preferred)
- Understanding of ISO 13485, ISO 14971, ISO 10993, and 21 CFR 820
- Great attitude, communication and time management
-
Senior Manufacturing Engineer
2 months ago
Plymouth, United States Laborie Full timeWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers...
-
Senior Manufacturing Engineer
2 months ago
Plymouth, United States Laborie Full timeWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers...
-
Senior Manufacturing Engineer
1 month ago
Plymouth, United States Laborie Medical Technologies Corp Full timeWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an...
-
Senior Manufacturing Engineer
2 months ago
Plymouth, United States Laborie Full timeWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers...
-
Senior Manufacturing Engineer
1 week ago
Plymouth, United States Laborie Full timeWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers...
-
Senior Manufacturing Engineer
1 week ago
Plymouth, United States Laborie Full timeWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers...
-
Senior Manufacturing Engineer
2 weeks ago
Plymouth, United States Interrad Medical Full timeSummaryThis role is responsible for all aspects, from planning to execution, of manufacturing the SecurAcath device, including managing suppliers, contract manufacturers, cleanroom operations, and working with engineering, operations, and quality.This position is based in Plymouth, MN (on-site).ResponsibilitiesManage manufacturing and process development of...
-
Senior Manufacturing Engineer
1 week ago
Plymouth, United States Interrad Medical Full timeSummaryThis role is responsible for all aspects, from planning to execution, of manufacturing the SecurAcath device, including managing suppliers, contract manufacturers, cleanroom operations, and working with engineering, operations, and quality.This position is based in Plymouth, MN (on-site).ResponsibilitiesManage manufacturing and process development of...
-
Quality Engineer
2 months ago
Plymouth, United States Engineering and Manufacturing Company Full timeJob DescriptionJob Description Job description We are seeking experienced Quality Engineers for an International Fastener Manufacturing Company for the Plymouth, MI area. Requirements of the position: Bachelor of Science Degree Preferred Experience Creating Quality Management Systems, APQP, PPAP's, 8D Corrective Action Systems Experience with Quarta 3, SPS,...
-
Sr. Manufacturing Engineer
1 month ago
Plymouth, United States Development Resource Group Full timeIn this exciting role as a Senior Manufacturing Engineer, you will have responsibility for executing a broad range of projects. Projects supported in this role can span from capacity expansion, equipment end of life replacement, yield improvement, technology change implementation, quality improvement and lean transformation initiatives. This role will...
-
Engineer, Manufacturing
4 weeks ago
Plymouth, United States ATR International Full timeJob Description: We are seeking an Engineer, Manufacturing for a very important client The position of Manufacturing Engineer, I within our EP business unit located at Plymouth, Minnesota In this role you will provide technical support to the production released catheter and introducer products and technical support to new product teams for design for...
-
Manufacturing Engineer
4 weeks ago
Plymouth, United States LanceSoft Full timeTitle: Manufacturing Engineer I Location: Plymouth, MN 55442 Duration: 09 Months Description: The position of Manufacturing Engineer, I within our EP business unit located at Plymouth, Minnesota. In this role you will provide technical support to the production released catheter and introducer products and technical support to new product teams for design...
-
Manufacturing Engineer
4 weeks ago
Plymouth, United States Global Technical Talent Full timeManufacturing Engineer Contract Duration 9 Months Job Description Evaluation of production equipment Production support and process validation Troubleshoot manufacturing process and equipment Protocol and report writing Generate and modify manufacturing process documentation The Manufacturing Engineer will work with cross-functional teams as required and...
-
Engineer, Manufacturing
4 weeks ago
Plymouth, United States SMS Staffing Inc. Full timeJob DescriptionJob DescriptionSMS Staffing Inc is Hiring Immediately for a skilled Manufacturing Engineer. Job Title: Manufacturing EngineerJob Location: Plymouth, MN, U.S.A.Job Type: Contract (possible extension)Pay: Starts at $42.00 an hourShift Structure: 9:00 am - 5:00 pm; ONSITE, Monday to Friday, 40 hours per weekAbout the Manufacturing Engineer Role:...
-
Engineer, Manufacturing
2 weeks ago
Plymouth, United States SMS Staffing Inc. Full timeJob DescriptionJob DescriptionSMS Staffing Inc is Hiring Immediately for a skilled Manufacturing Engineer. Job Title: Manufacturing EngineerJob Location: Plymouth, MN, U.S.A.Job Type: Contract (possible extension)Pay: Starts at $42.00 an hourShift Structure: 9:00 am - 5:00 pm; ONSITE, Monday to Friday, 40 hours per weekAbout the Manufacturing Engineer Role:...
-
Engineer, Manufacturing
3 weeks ago
Plymouth, United States Manpower Group Inc. Full timeOur client, the medical device manufacturing industry, is seeking a manufacturing engineer to join their team. Job Title: Manufacturing Engineer Location: Plymouth , MN Pay Range: $40- $44 What’s the Job? The position of Manufacturing Engineer is within our EP business unit located at Plymouth, Minnesota. In this role, you will provide technical...
-
Engineer, Manufacturing
4 weeks ago
Plymouth, United States Experis Full timeOur client, the medical device manufacturing industry, is seeking a manufacturing engineer to join their team. Job Title: Manufacturing Engineer Location: Plymouth , MN Pay Range: $40- $44 What's the Job? The position of Manufacturing Engineer is within our EP business unit located at Plymouth, Minnesota. In this role, you will provide technical...
-
Senior Director Manufacturing
3 weeks ago
Plymouth, United States Laborie Full timeWe believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.We support and empower our employees to grow their careers in...
-
Senior Director Manufacturing
3 weeks ago
Plymouth, United States Laborie Full timeWe believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.We support and empower our employees to grow their careers in...
-
Senior Director Manufacturing
1 week ago
Plymouth, United States Laborie Full timeWe believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.We support and empower our employees to grow their careers in...