NPI Quality/Validation Engineer
Full-time
Merrimack Manufacturing
Position Overview:
This position supports design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. This role includes generation and maintenance of control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity. The role will also provide support to the organizational goals by leading improvement projects to increase efficiency and compliance across the site. Responsibilities:
This position supports design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. This role includes generation and maintenance of control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity. The role will also provide support to the organizational goals by leading improvement projects to increase efficiency and compliance across the site. Responsibilities:
- Leverage your engineering and technical experience to evaluate new products, manufacturing processes and ensure compliance with applicable regulatory standards throughout the New Product Introduction process
- Provide input to the development, review, and update of User Requirements, critical quality attributes, and other design documentation
- Lead project teams through validation protocol generation, execution, documentation organization, report writing, etc. while meeting schedule for final approval and release
- Conduct investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills
- Lead the evaluation and identification of validation requirements and sampling plans for new, and changes to, manufacturing processes, test methods, and equipment
- Develop inspection procedures and sampling plans for new production, continuous improvement of process controls, and improved workflow/worker satisfaction
- Assist in the development, implementation, and approval of Device Master Records, Device History Records, and Risk Management Files for new products
- Provide guidance and assistance on the assessment of new and changes to existing manufacturing equipment, ensuring proper enrollment into QMS systems and that Validation requirements are met
- Lead improvement projects to increase efficiency and compliance within Merrimack Manufacturing’s Quality Management System
- Contain defective product and processes systemically, participate in Material Review Board (MRB) meetings, track and follow through with nonconformance investigations assigned to internal and external team members.
- Support and contribute towards the success of external audits, whether conducted by the FDA, a Notified Body, other regulatory bodies, or external customers
- At least 3 years of experience in Medical Device Manufacturing or other similarly regulated industry such as Aerospace, Military, etc.
- Strong knowledge of CFR Part 820 and ISO 13485 required
- Lean or Six Sigma certification preferred
- Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting engineering specifications
- Knowledge of Design Transfer and introduction of new product processes and deliverables
- Strong knowledge of tolerance stack up calculations and calibration best practices
- Strong organization, communication, and time management skills; Project Management experience preferred
- Knowledge of industry standards and best practices for Software Validation, Controlled Environments, Biocontamination Controls, and Gamma Irradiation also preferred
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the NPI Quality/Validation Engineer in Manchester, NH vacancy
$65k - $115k
...We are actively seeking both Supplier Quality Engineers (SQE) and Senior Supplier Quality Engineers... ...both New Product Introduction (NPI) and sustaining manufacturing operations... ...supplier certifications, quality records, validation documentation, and compliance records Support...SuggestedContract workImmediate startRemote workMonday to FridayTop Prospect Group
Manchester, NH3 days ago- ...The Supplier Quality Engineer is responsible for leading supplier quality activities during design transfer and process/product validation. This role ensures supplier compliance to applicable requirements... ...management Experience supporting NPI or design transfer activities...SuggestedContract work
DEKA Research & Development
Manchester, NH21 hours ago - ...TITLE : Senior System Validation Engineer DUTIES: Validating complex embedded software interactions spanning propulsion, ADAS/AD, body, infotainment, and connected services. Lead integration and validation of embedded software at the component, subsystem, and full...SuggestedFull timeImmediate start
Stellantis
Manchester, NH4 days ago - ...This role focuses on driving quality standards across engineering and manufacturing processes, ensuring products meet strict compliance and performance requirements. You'll play a key role in maintaining systems, inspecting components, and supporting cross-functional...SuggestedWork at officeLocal area
Michael Page
Manchester, NH21 hours ago - ...is looking for a technically deep, process-driven Software Quality Assurance Engineer to join our cloud engineering team. This is an individual... ...Specifications (SRS), Software Design Documents (SDD), Verification & Validation Plans and Reports, and Software Risk Management Files...Suggested
DEKA Research & Development
Manchester, NH3 days ago - ..., has an immediate opening for a Junior Verification & Validation Test Engineer to work in a dynamic medical device R&D environment. Test Engineering... ...skills Experience in medical devices, knowledge of FDA Quality System Regulations (QSRs) and/or ISO 13485, and other...Full timeImmediate start
- ...Development, located in Manchester, NH, is seeking a Verification & Validation Test Engineer to work in a dynamic medical device R&D environment. This... ...toward regulatory and agency submissions Authoring Quality Plans, Test Summaries, and other documents What you need...Full time
- ...As a Senior Manufacturing Engineer at DEKA, you’ll play a critical... ...designs into scalable, high-quality, and regulatory-compliant manufacturing... ...role which includes NPI or CM experience. ~ Experience... ...including GD&T, design validation, and inspection. ~ Demonstrated...
DEKA Research & Development
Manchester, NH22 days ago - ...production , delivering precision, quality, and on-time performance on custom-engineered products. Our capabilities... ...effectiveness (OEE). Design, develop, validate, and implement machining fixtures... ...New Product Introduction (NPI) activities by developing manufacturing...Contract workLocal areaFlexible hours
Granite State Manufacturing
Manchester, NH7 days ago - ...for a dynamic, results driven and inventive Senior Software Quality Assurance Engineer to support the development of life-changing medical... ...Support device development teams through delivery of modern, validated software tools Use experience within software product development...Work at office
DEKA Research & Development
Manchester, NH3 days ago - ...that’s uniquely yours. MINIMUM QUALIFICATIONS: ~ B.S. in Engineering discipline (Electrical, Acoustic, or Software preferred) ~3+... ...System Analysis experience preferred Familiarity with Quality Management System standards such as ISO 9001 or AS9100 preferred...Full timeContract work
Gentex Corp
Manchester, NH16 hours ago - ...The Supplier Quality Engineer II impacts customer satisfaction and continual improvement through monitoring, managing, and resolving issues related to supplier quality performance. This role develops supplier relationships, audits supplier capabilities and quality systems...
E-Solutions
Merrimack, NH3 days ago - ...market, representing how TTM's time-critical, one-stop design, engineering and manufacturing services enable customers to reduce the time... ...is responsible for maintaining and continuously improving the Quality Management System (QMS) to ensure compliance with customer,...Permanent employmentContract workWork experience placementWork at officeLocal areaFlexible hours
TTM Technologies
Londonderry, NH3 days ago - ...Hudson, NH Description: Reporting to the Quality Manager, the Quality Engineer will be located at the Hudson, NH corporate facility. This position will be responsible for all aspects of Quality Engineering within the company including the following: Maintain...
kSARIA
Chester, NH4 days ago $90k - $120k
...Overview This is a hands‑on Quality Engineer role supporting mechanical products through production, testing, and process improvement. You... ...and customer deliverables Perform inspections and testing to validate product conformance using various tools Drive continuous improvement...Local areaMichael Page
Derry, NH21 hours ago- ...This positon will support manufacturing quality operations in a dynamic, fast-paced,... ...devices for design verification, design validation, and commercial production. RESPONSIBILITIES... ...process and investigations. Author Engineering Change Orders (CO); support CO...Full timeWork at office
- ...POSITION SUMMARY Executes the quality control program such that continuous production is achieved and product is consistent with established... ...quality and coordinates necessary actions with Quality Engineers. Oversees all the operations in the Quality Control...Immediate startFlexible hours
Granite State Manufacturing
Manchester, NH6 days ago - Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Quality Systems Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and...Full time
- ...This position will support manufacturing quality operations in a dynamic, fast-paced,... ...devices for design verification, design validation, and commercial production. RESPONSIBILITIES... ...and devices Use experience with engineering and technology to ensure compliance...Work at office
- ...capabilities to meet increasing demand and to expand into new markets and antenna technologies. Haigh-Farr is seeking a Quality Engineer with a demonstrated background in roles where a high attention to detail were required. The successful candidate will be responsible...Work experience placementFlexible hours
- ...Description Job Description We are seeking a Manufacturing Engineer to drive process development, build execution, and the transition... ...the design transfer process to ensure on-time delivery of high-quality products that meet all performance criteria. Skills you will...
DEKA Research & Development
Manchester, NH27 days ago - ...Manufacturing LLC is recruiting for a Manufacturing Engineer for process development and improvement... ...methods to improve manufacturing quality across established product lines... ...rejection Support and lead equipment validation and training activities Interface with...
Merrimack Manufacturing
Manchester, NH15 days ago - ...asked to assist on projects and tasks outside of your primary responsibilities. Qualifications Bachelor’s (or Master’s) Degree in engineering, science, health, or related technical field. Strong leadership and project management experience. Ability to exercise...Work at officeFlexible hours
GZA
Hooksett, NH21 hours ago - ...QA Electrical Engineer Fireye is seeking a Quality Assurance Electrical Engineer, for its business in Derry, New Hampshire! Fireye provides combustion and detection fire safety solutions that protect people and property. The QA Electrical Engineer is responsible...
Spectrum Safety Solutions
Derry, NH21 hours ago - ...as well as cost efficiency. Ensures the engineering team and other manufacturing departments... ...and improvement to improve manufacturing quality and efficiency. Determine and eliminate... ...Support legacy and new product introduction (NPI) projects working with a team of Program...Local areaFlexible hoursAfternoon shift
Granite State Manufacturing
Manchester, NH27 days ago - ...Summary The Design Verification Test Engineer is responsible for defining, developing... .... This role works closely with design, quality and manufacturing teams to identify defects... ...and closure using bug‑tracking tools Validate integration of hardware with firmware...
Fireye, LLC
Derry, NH15 days ago - ...optical products in both New Product Introduction (NPI) and product transition environments. The engineer ensures complete test coverage from component through... ...a safe, compliant working environment. • Ensure quality and accuracy of work while maintaining technical...Contract workWork at officeRelocation
Intelligent Manufacturing Solutions
Londonderry, NH17 days ago - ...Description Job Description JOB DESCRIPTION TITLE: Test Engineer Reports to: Manager, Technical Operations Supervises: Not... ..., and secure environment is maintained. Responsible for the quality and accuracy of own work. ACCOUNTABILITIES/ SCOPE ***...Contract workWork at officeFlexible hours
Intelligent Manufacturing Solutions (IMS)
Manchester, NH14 days ago - ...Job Description Job Description POSITION SUMMARY The Quality Engineering Manager is responsible for overseeing all manufacturing quality assurance activities for precision machined parts, welded fabrications, and complex assemblies, particularly within strict defense...Flexible hours
- ...to hire a fulltime permanent Automation Engineer supporting automated manufacturing equipment... ...teams to specify, engineer, integrate, validate and support automated manufacturing... ...contact with operations, engineering and quality departments to understand and address observed...Permanent employmentFull timeRemote work
InnoTech Staffing
Manchester, NH13 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to NPI Quality/Validation Engineer. Be the first to apply!
Related searches
- customer quality engineer Manchester, NH
- quality systems engineer Manchester, NH
- quality engineer Manchester, NH
- supplier quality engineer Manchester, NH
- quality improvement rn Manchester, NH
- quality equipment Manchester, NH
- quality management nurse Manchester, NH
- quality distribution Manchester, NH
- quality lead Manchester, NH
- quality intern Manchester, NH