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NPI Engineer, Deployment Readiness
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NPI Project Manager
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NPI Quality Engineer
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Ct - 4041 Assistant Program Manager
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NPI Quality Engineer
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Engineering Director, Protected Communications
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Capex Sourcing Manager
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Amazon Westborough, United StatesAre you inspired by invention? Is problem solving through teamwork in your DNA? We apply advances in robotics and software to solve real-world problems that delight our customers' experiences in ways we can't even imagine yet. · Amazon Robotics is located in the greater Boston a ...
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Program Manager, Software/firmware
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Supplier Quality
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Quality Engineer II
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Quality Engineer II
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Quality Engineer II
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Assistant Program Manager Manufacturing
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Coghlin Companies Inc Westborough, United StatesJob Summary The Assistant Program Manager (APM), together with the Program Manager (PM), is the primary point of contact for the customer. Together the APM and the PM lead a cross-functional team to ensure an exceptional customer experience is realized. They also work together to ...
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Production Control Manager, Robotics
1 week ago
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Sr Supply Chain Manager
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Production Control Manager, Robotics
6 days ago
Amazon Westborough, United StatesProduction Control Manager, Amazon Robotics · Job ID: | Services LLC · Are you inspired by invention? Is problem solving through teamwork in your DNA? We apply advances in robotics and software to solve real-world problems that delight our customers' experiences in ways we can' ...
Sr. NPI - Westborough, United States - Resonetics
Description
:The Resonetics Sr.
NPI (New Product Introduction) Engineer is a key member of the team ensuring Resonetics' ability to develop cutting edge medical device products and manufacturing capabilities from early stage design through successful market introduction and launch.
They work in unison as a core team member with the Product Development and Quality Engineering functions to implement new technologies and processes, and ensure successful and timely transfer to clinical, pilot-line, and commercial production while meeting established goals (i.e., safety, quality, delivery, cost, and productivity).
The Sr.NPI Engineer develops, selects, and optimizes systems for component and assembly manufacturing based on planned demand, location, and quality requirements.
In addition, the Sr. NPI Engineer plays a key role in selection, vetting, and coordination of external supply chain. As programs progress into commercial manufacturing, the Sr.NPI Engineer acts as a technical liaison and key member of the transfer team to facilitate efficient training of production resources.
As an experienced resource, the Sr.NPI Engineer is expected to help establish best practices, train junior resources, and resolve complex technical and business challenges using formal engineering rigor and data driven decisions.
RESPONSIBILITIES:
Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.
Generate and modify manufacturing process documentation and assure that manufacturing processes and related documentation follow established policies and procedures per Resonetics' established Quality Management System.
Utilize LEAN, Six Sigma, DMAIC and other process improvement tools and principles as appropriate for day-to-day problem solving and continuous improvement.
Write and execute process and equipment validations (IQ/OQ/PQ/MVP/TMV), as well as associated risk management activities (PFMEA/Risk Assessment).
Drive utilization of process improvement techniques to solve technical problems and make scale-appropriate equipment and process recommendations.
Design and prepare engineering reports, communicate results to technical team, customer, and leadership audiences.
Complete and manage Capital Equipment Requests associated with project work.
Create process documentation and execute training where applicable (Manufacturing Process, Equipment Setup, Preventive Maintenance etc.).
REQUIRED QUALIFICATIONS:
(BS or MS) in relevant Engineering discipline or equivalent experience.
Minimum of 6 years experience in a manufacturing environment working in an engineering role.
Strong communication skills, comfortable with leading and providing project status updates at the team, customer, and leaderships levels.
Demonstrated work ethic and understanding of deadline management.
Strong analytical skills with the ability to process operational or technical data and translate the output into a business result or opportunity.
Experience with Statistical Process Control (SPC).
Proficient in SolidWorks (or equivalent) for tooling/fixture design. Well versed in GD&T and generation of technical drawings.
Excellent writing skills, able to write detailed reports, comprehensive manufacturing procedures and validation reports/protocols.
Training and/or experience in formal problem-solving techniques (Cause & effect analysis, 5 Why's, etc.)
Effective interpersonal skills and adeptness in working with culturally diverse employee population.
Ability to drive task clarity in a fast-paced environment with cross-functional stakeholders.
PREFERRED QUALIFICATIONS:
Certification or training in Lean Six Sigma methodology and DMAIC principles.
Project management, planning, and leadership skills.
Experience with catheter processing equipment including hot boxes, laminators, split die bonders and tipping machines
Experience working in a medical device or regulated environment.
PHYSICAL DEMANDS:
Standing and walking for short periods of time
Ability to use a microscope, including manipulating small objects under a microscope
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