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Process V&V Engineer

Katalyst Healthcares and Lifesciences

Bedford, Massachusetts • Today

Full-time

Engineer I-III, Thermal-Hydraulic Safety Analysis & V&V

X-energy

Remote or Rockville, Maryland • Today

Full-time

USD 85,000.00 - 135,000.00 per year

Medical Device V&V engineers

Katalyst Healthcares and Lifesciences

Remote or New Jersey • Today

Full-time

Engineer IV, Safety Analysis & V&V

X-energy

Remote or Rockville, Maryland • Yesterday

Full-time

USD 160,000.00 - 185,000.00 per year

Navigation Systems V&V Engineering Manager

Johnson & Johnson

Boston, Massachusetts • Today

Full-time

USD 117,000.00 - 201,250.00 per year

Senior Robotics Verification & Validation (V&V) Engineering Manager

Johnson & Johnson

Boston, Massachusetts • Today

Full-time

USD 137,000.00 - 235,750.00 per year

Senior Software Verification & Validation Engineer

Draper

Cambridge, Massachusetts • Today

Full-time

USD 75,000.00 per year

Job Details

Skills

Continuous Monitoring
Product Engineering
Supply Chain Management
Collaboration
Research and Development
Design For Manufacturability
Risk Management
FMEA
Test Methods
Auditing
Conflict Resolution
Problem Solving
Value Stream Mapping
Performance Monitoring
APQP
Management
Continuous Improvement
Biomedicine
Customer Engagement
Manufacturing
Leadership
IQ
OQ
PQ
Electronics
Commodities
Attention To Detail

Summary

Summary:
chieve state of high-quality performance at our Supplier partners through the application and practice of Advanced Product Quality Planning APQP , Supplier Qualification (Audit, Quality Agreement/Change Notice Agreement), and continuous monitoring the performance supplier to drive zero defect through Supplier Corrective Actions and notification. You will fill a high-profile, cross functional position and play an integral role enabling development and production flow of IGTDs critical supply base. You will work in close coordination with Product Engineering, Supply Chain and Production and Suppliers to execute effective, creative and smart supply chain strategies to achieve production goals.

Roles & Responsibilities:

Perform Process Validation and Verification across Spectrawave IGTD portfolios for Consoles and Catheter parts.
Collaborate with R&D and Quality Design Assurance in Design for Manufacturability and Part Risk management per DFMAE and PFMEA.
Perform Process Validation , Verification, Test Method Validation, and assess CTS/CTQ criteria per APQP requirement for +700 parts.
Support Supplier Qualification including Audit, Quality Agreement and Change Notice Agreement.
Perform Problem solving in the case of FAI and APQP failure.
Deep dive Value Stream mapping across process.
Conducts thorough investigations of defects to determine if they are supplier-caused and implement corrections using the SCAR process.
Proactively manage, monitor, and troubleshoot supplier-related issues for quality of components, sub-assemblies, and assemblies including monitoring trends and managing Supplier Improvement and Supplier Quality Performance Monitoring.
Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary.
Develop and oversee process validation plans, including equipment qualifications, with suppliers and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations.

Requirements:

Bachelor Degree engineering (Master Degree is plus) with a preference in Mech Engr or Biomedical Engr
10+ years of relatable engineering experien ce (Manufacturing Engineer and/or Product Quality that works in V & V).
5+ yrs of experience in a leadership role resolving non-conformance and Mnfg Process V & V.
Subject Matter expert in IQ, OQ, PQ
SO 13485 Lead Auditor certified is plus.
Experienced in plastic , metal, electronics commodities.
Strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally and complete assignments with accuracy and a high attention to detail Min 20% travel time .

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: aed4feed3a484d2ce2f6726626efb27b
Posted 1 day ago

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Bedford, Massachusetts

•

Yesterday

Position Title: Sr. Supplier Quality Engineer (PHIAJP00004186) Location: Bedford MA Duration: 12 months Positions Requested: 2 Hours per Week: 40 (8 hrs/day) Notes from the manager: Major focus in experienced Process Validation, Verification across plastic, metal and electronics along with problem solving for candidates to support +700 parts for part qualification for Spectrawave products. The product contains Catheter and Console (System) products. Manufacture engineering, Product Quality, and/

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Contract

50 - 55

Senior Validation Engineer I

Lexington, Massachusetts

•

Yesterday

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

Full-time

USD 104,541.00 - 141,240.00 per year

Lead Product Quality Engineer - Aerospace & Defense

Massachusetts

•

Today

About Us Founded in 2015 to develop the world's first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. We build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through our vertically integrated capabilities, including scalable additive manufacturing and precision machining

Full-time

USD 117,400.00 - 161,500.00 per year

Validation Engineer 3 - Product R&D

Bedford, Massachusetts

•

Today

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious mind

Full-time

USD 80,400.00 - 140,300.00 per year