Sr. Systems Engineer
1 month ago
The Senior Systems Engineer will spearhead the development of new product development efforts at Access Vascular Inc. This role involves the preparation and maintenance of engineering documentation, support of design verification and validation activities including interfacing with external vendors, third party test labs, and internal functions, and ensuring that best engineering practices and efficient processes are employed to meet technical and business objectives.
Duties and ResponsibilitiesThis may include but is not limited to the following:
- Design & Development: Lead the design and development of a medical device with electrical, software and mechanical features.
- Project Management: Prepare and execute project plans for product development, including defining design concepts, synthesizing marketing input, generating design input, and supporting design verification and validation. Identify appropriate internal and external resources required to efficiently conduct design and development efforts.
- Coordination: Oversee and coordinate device development with catheter development to ensure comprehensive system product requirements are met.
- Technical Leadership: Provide technical leadership and direction to engineers, technicians, and consultants involved in device design and development.
- Documentation & Compliance: Generate and update design input and risk management documents. Support the compilation and submission of regulatory filings and patents.
- Verification & Validation: Support system-level design verification and validation efforts. Devise and perform analysis and testing of design outputs to justify design input requirements and design decisions.
- Design Improvements: Analyze data for conformance to design specifications and recommend and implement design improvements to product platforms.
- Consulting: Provide consulting support to other product development groups for regulatory compliance, quality system, and supply chain management responsibilities.
- Educational Background: B.S. in engineering discipline (e.g., Electrical, Mechanical, Biomedical, Software). M.S. preferred.
- Experience: 10+ years' experience in medical device product development, including FDA regulated devices covered by 510(k) or PMA. Experience with mechanical, electrical, and software systems required; experience with catheter technologies preferred.
- Leadership: Proven effective motivational leadership skills, with experience in building and managing teams to deliver product designs on schedule.
- Technical Proficiency: Proficient in the design of systems with mechanical, electrical, and software elements. Capable of creative problem solving, quick comprehension, and skeptical analysis.
- Communication: Excellent communication skills to support working independently and within a team. Efficient and effective communicator, both verbally and in writing.
- Regulatory Knowledge: Intimate knowledge of applicable standards (e.g., ISO 13485, ISO 14971, FDA QSR).
- Customer Service: Strong, passionate understanding of and commitment to customer service.
- Software Skills: Proficient with Microsoft Office Software products, including MS Project.
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .
-
Optical Systems Engineer
4 days ago
Billerica, Massachusetts, United States FLIR Systems Full timeJob Summary:The Optical Engineer will work with the interdisciplinary engineering team designing and developing new optical prescriptions for complex zoom and multispectral imaging systems for new and modified existing optical systems. The job will design, develop, tolerance, and analyze complex IR and multispectral optical systems. The position will also...
-
Sr. Manufacturing Engineer
2 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 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 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
6 days 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
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....
-
Sr. Manufacturing Engineer
2 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 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
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
4 weeks 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....
-
Principal Systems Engineer
2 months ago
Billerica, United States Teledyne FLIR Full timeSeeking a talented Senior or Principal Systems Engineer (depending on years of experience in systems Engineering) to work in systems engineering team to lead US Government DOD full system engineering efforts in program and product development. In this role, you will work to understand customer needs, identify & manage performance requirements, and provide...
-
Principal Systems Engineer
2 months ago
Billerica, United States Teledyne FLIR Full timeSeeking a talented Senior or Principal Systems Engineer (depending on years of experience in systems Engineering) to work in systems engineering team to lead US Government DOD full system engineering efforts in program and product development. In this role, you will work to understand customer needs, identify & manage performance requirements, and provide...
-
Sr. Mechanical Engineer
2 months ago
Billerica, United States ASMPT NEXX, Inc. Full timeSummary: The Senior Mechanical Engineer is a member of the Panel Engineering department, focusing on mechanical designs that improve/enhance performance of the Panel ECD equipment. The individual will perform engineering design conceptualization, development, testing, and release for various components and assemblies on the equipment. The individual will...
-
Sr. Mechanical Engineer
2 months ago
Billerica, United States ASMPT NEXX, Inc. Full timeSummary: The Senior Mechanical Engineer is a member of the Panel Engineering department, focusing on mechanical designs that improve/enhance performance of the Panel ECD equipment. The individual will perform engineering design conceptualization, development, testing, and release for various components and assemblies on the equipment. The individual will...
-
Optical Engineer 2
6 days ago
Billerica, United States FLIR Systems Full timeTeledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration...
-
Senior Thermal Engineer
2 weeks ago
Billerica, United States boston semi equipment Full timePosition Summary The Sr. Mechanical Engineer - Thermal is responsible for performing the essential duties and responsibilities in their role.You will have the chance to make an impact and immediately be an integral part of our team, with the opportunity to advance your career using our specific career path model.To be successful as an Sr. Mechanical Engineer...
-
Validation Engineer
3 weeks ago
Billerica, United States Massachusetts Maritime Academy Full timeSequoia is seeking a Sr. Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. Responsibilities...
-
Sr Manufacturing Engineer
3 months ago
Billerica, United States LanceSoft Full timeJOB DESCRIPTIONTop 3 technical skills that are required for the role:Evaluate, develop, validate and implement manufacturing processes and process improvements for Medical devices or regulated industriesProblem solving, root cause investigation, experience with CAPAunderstanding of lean manufacturing and six sigma toolsEducation Required:Bachelor of Science...
-
Sr Manufacturing Engineer
3 months ago
Billerica, United States LanceSoft Full timeJOB 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...
-
Senior Thermal Engineer
2 weeks ago
Billerica, United States boston semi equipment Full timeNote: We do not work with staffing agencies, instead, your application will be reviewed by our internal hiring team. Please apply directly to BSE.Position Summary The Sr. Mechanical Engineer - Thermal is responsible for performing the essential duties and responsibilities in their role. You will have the chance to make an impact and immediately be an...