Sr Manufacturing Engineer
4 months ago
JOB DESCRIPTION
Top 3 technical skills that are required for the role:
Evaluate, develop, validate and implement manufacturing processes and process improvements for Medical devices or regulated industries
Problem solving, root cause investigation, experience with CAPA
understanding of lean manufacturing and six sigma tools
Education Required:
Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.
Years' Experience Required:
Minimum of 5 years in medical device or pharmaceutical industry in Manufacturing Engineering, Packaging or Quality Engineering.
Requires practical knowledge and demonstrated competence within manufacturing engineering, process development, packaging engineering typically obtained through advanced education combined with experience.
Knowledge and working experience of Lean manufacturing and six sigma practices
Knowledge and general understanding of ISO 11607 part 2, ASTM and ISTA package test methods is preferred
Will the contractor be working 40 hours a week? Any overtime for this role? 40 hours per week, no overtime
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? On-site 4-5 days per week (Billerica/Bedford MA)
What is your timeline for scheduling interviews? ASAP
What product line will this person support? Cardiac Ablations Solutions, cardiac mapping and navigation systems and catheter-based cardiac ablation technologies
The Manufacturing Engineer will lead and support various process improvement and remediation activities. Activities to include but not limited to the following.
Fixture design, procurement, installation, validation
Process map, process development, time studies, line layouts
Labeling system set-up, system updates, documentation updates
Process validation IQ/OQ/PQ
Author, update, and execute engineering Protocols and closing Reports
Documentation PLM system updates (BOM, SOP, visual aids, drawings, Work instructions)
Conduct and support Root Cause Analysis, Measurement System Analysis, gemba walks, update PFMEA and control plans
Support and process Non-Conforming Material Reports (NCMRs), CAPAs and Audit Findings
Weekly reports, updates, administrative task (as needed)
Conduct testing (as needed)
Manufacturing and engineering support (as needed)
Minimum Requirements
Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.
Minimum of 5 years in medical device or pharmaceutical industry in Manufacturing Engineering, Packaging or Quality Engineering.
Requires practical knowledge and demonstrated competence within manufacturing engineering, process development, packaging engineering typically obtained through advanced education combined with experience.
Knowledge and working experience of Lean manufacturing and six sigma practices
Knowledge and general understanding of ISO 11607 part 2, ASTM and ISTA package test methods is preferred
Work location:
On-site: Bedford, MA and Billerica MA
-
Sr. Manufacturing Engineer
3 weeks ago
Billerica, United States Medtronic Full timePosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971. Demonstrate...
-
Sr. Manufacturing Engineer
3 weeks ago
Billerica, United States Medtronic Full timePosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971. Demonstrate...
-
Sr. Manufacturing Engineer
3 weeks ago
Billerica, United States Medtronic Full timePosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971. Demonstrate...
-
Sr. Manufacturing Engineer
2 weeks ago
Billerica, United States Medtronic Full timeJob Description Position Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and...
-
Sr. Manufacturing Engineer
4 weeks ago
Billerica, United States Medtronic Full timePosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971....
-
Sr. Manufacturing Engineer
3 weeks ago
Billerica, United States Medtronic Full timeJob DescriptionPosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO...
-
Sr. Manufacturing Engineer
4 weeks ago
Billerica, United States Medtronic Full timeJob DescriptionPosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO...
-
Sr. Manufacturing Engineer
2 days ago
Billerica, United States Medtronic Full timePosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971....
-
Sr. Manufacturing Engineer
1 month ago
Billerica, United States Medtronic Full timePosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971....
-
Sr. Manufacturing Engineer
1 month ago
Billerica, United States Disability Solutions Full timePosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971....
-
Sr. Manufacturing Engineer
4 weeks ago
Billerica, MA, United States Medtronic Full timeJob DescriptionPosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO...
-
Sr. Manufacturing Engineer
1 month ago
Billerica, Massachusetts, United States of America Medtronic Full timePosition Description: Sr. Manufacturing Engineer for Medtronic, Inc., located in Billerica, MA. Responsible for providing engineering guidance and project support for the design, development and optimization of products, processes, tooling, and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971....
-
Manufacturing Process Engineer
1 month ago
Billerica, Massachusetts, United States Entegris Full timeAt Entegris we are committed to providing equal opportunity to all employees and applicants. Our policy is to recruit, hire, train, and reward employees for their individual abilities, achievements and experience without regard to race, color, religion, sexual orientation, age, national origin, disability, marital or military status.Billerica, MA Full time...
-
Manufacturing Process Engineer
1 week ago
Billerica, Massachusetts, United States LanceSoft Full timeJob SummaryLanceSoft is seeking a highly skilled Manufacturing Process Engineer to join our team. As a key member of our production team, you will be responsible for designing and implementing efficient manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.Key...
-
Senior Manufacturing Engineer
3 days ago
Billerica, Massachusetts, United States Medtronic Full timeJob SummaryWe are seeking a highly skilled Senior Manufacturing Engineer to join our team at Medtronic, Inc. in Billerica, MA. As a key member of our engineering team, you will be responsible for providing technical guidance and support for the design, development, and optimization of products, processes, tooling, and equipment.Key ResponsibilitiesDevelop...
-
Senior Manufacturing Engineer
3 days ago
Billerica, Massachusetts, United States Medtronic Full timeJob SummaryWe are seeking a highly skilled Senior Manufacturing Engineer to join our team at Medtronic, Inc. in Billerica, MA. As a key member of our engineering team, you will be responsible for providing technical guidance and support for the design, development, and optimization of products, processes, tooling, and equipment.Key ResponsibilitiesDevelop...
-
Senior Manufacturing Engineer
2 weeks ago
Billerica, Massachusetts, United States Medtronic Full timeJob SummaryMedtronic is seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of our engineering organization, you will be responsible for providing technical guidance and support for the design, development, and optimization of products, processes, tooling, and equipment.Key Responsibilities:Develop and implement...
-
Manufacturing Process Engineer
1 week ago
Billerica, Massachusetts, United States LanceSoft Full timeJob SummaryLanceSoft is seeking a highly skilled Manufacturing Process Engineer to join our team. As a key member of our production team, you will be responsible for designing and implementing efficient manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.Key...
-
Senior Manufacturing Engineer
3 days ago
Billerica, Massachusetts, United States Medtronic Full timeJob SummaryWe are seeking a highly skilled Senior Manufacturing Engineer to join our team at Medtronic, Inc. in Billerica, MA. As a key member of our engineering team, you will be responsible for providing technical guidance and support for the design, development, and optimization of products, processes, tooling, and equipment.Key ResponsibilitiesDevelop...
-
Lead Optical Manufacturing Engineer
2 weeks ago
Billerica, Massachusetts, United States OmniGuide Inc Full timeLead Optical Manufacturing EngineerCompany Overview:OmniGuide Inc. is a leading innovator in the medical device sector, focusing on advanced laser technologies for surgical applications. Our commitment to excellence has positioned us as a key player in the development of Thulium and Co2 Laser systems, as well as fiber laser technology, enhancing surgical...
