Top 797 validation engineer Jobs in devens ma

Quality Engineer- New Product Development
SMC Ltd. —Devens, MA
- $100,000 - $130,000 a year
- Full-time
- Microsoft Word
- Background check
- Computer literacy
- Paid holidays
- Disability insurance
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Software Design Quality Engineer
Philips —Bedford, MA
- $102,480 - $163,968 a year
- Full-time
- Computer Science
- 5 years
- Travel
- Health savings account
- Employee stock purchase plan
Project Engineer - Plastic Injection Molding
EPTAM Precision Plastics —Lancaster, MA
- $90,000 - $100,000 a year
- Full-time
- CAD
- Basic math
- Mid-level
- Health insurance
- Dental insurance
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Principal Mechanical Engineer
Brooksource —Boxborough, MA
- $65 - $80 an hour
- Contract
- 5 years
- Bachelor's degree
- Mentoring
- Health savings account
- Paid holidays
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Mechanical Engineer
FootBridge —Chelmsford, MA
- $35 - $50 an hour
- Full-time
- Mid-level
- Analysis skills
- 2 years
- Health insurance
- Dental insurance
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5d
Quality Validation Engineer
Avantor —Devens, MA
- $78,000 - $125,350 a year
- Full-time
- Hybrid work
- Computer Science
- Engineering
- Mid-level
Manufacturing Engineer - Senior
Intrinsic Therapeutics —Woburn, MA
- $135,000 - $140,000 a year
- Full-time
- Background check
- CAD
- Bachelor of Science
- Health savings account
- Health insurance
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Lead Software Engineer (AWS)
Kingfisher Company Inc. —Lowell, MA
- $80,000 - $120,000 a year
- Full-time
- 7 years
- Computer Science
- Office
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5d
Sr Engineer, Product
Getinge —Merrimack, NH
- $95,000 - $120,000 a year
- Extended hours
- Microsoft Excel
- 5 years
- Engineering
- Commuter assistance
- Disability insurance
Sr Engineer, Quality Operations
Getinge —Merrimack, NH
- $95,000 - $120,000 a year
- Extended hours
- 5 years
- Engineering
- Office
- Commuter assistance
- Disability insurance
Systems Integration & Test Engineer
The Structures Company, LLC —Chelmsford, MA
- $70.48 an hour
- Contract
- Mid-level
- 3 years
- Analysis skills
- Health insurance
- Dental insurance
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Human Factors Engineering - Associate Engineering Fellow
Takeda Pharmaceutical —Lexington, MA
- $154,400 - $242,550 a year
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
- Paid holidays
- Disability insurance
Sr. Test and Validation Engineer 2nd shift - CLEARANCE REQUIRED
Raytheon —Andover, MA
- $86,800 - $165,200 a year
- Full-time
- Forklift
- Continuous improvement
- Senior level
- Paid holidays
- Disability insurance
Engineer II, Product
Getinge —Merrimack, NH
- $90,000 - $110,000 a year
- Extended hours
- Microsoft Excel
- Engineering
- Mid-level
- Commuter assistance
- Disability insurance
2d
Plastics Engineer
Hy-Ten Plastics —Milford, NH
- $70,000 - $90,000 a year
- Full-time
- Background check
- CAD
- 5 years
- Health insurance
- Dental insurance
Quick Apply
Sr Engineer (Software HIT Test)
Fresenius Kabi —North Andover, MA
- $145,000 - $155,000 a year
- Full-time
- Hybrid work
- Background check
- Azure
- Engineering
- Wellness program
- Paid holidays
Quick Apply
LTAMDS Production Lead Systems Engineer
Raytheon —Tewksbury, MA
- $132,400 - $251,600 a year
- Full-time
- Windows
- Travel
- Organizational skills
- Paid holidays
- Disability insurance
Senior Systems Engineer - Air Defense Systems
Raytheon —Tewksbury, MA
- $86,800 - $165,200 a year
- Full-time
- 5 years
- Office
- Travel
- Paid holidays
- Disability insurance
3d
Senior Controls Engineer
Invio Automation —Hudson, NH
- Engineering
- Continuous improvement
- Travel
Quick Apply
Sr. Test and Validation Engineer - 4th Shift
Raytheon —Andover, MA
- $86,800 - $165,200 a year
- Full-time
- Forklift
- Senior level
- 2 years
- Paid holidays
- Disability insurance

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validation engineer jobs near devens ma

Quality Engineer- New Product Development

SMC Ltd. -
Devens, MA

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Job Details

Full-time
$100,000 - $130,000 a year

Benefits

Paid holidays
Disability insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Employee assistance program
Vision insurance

Qualifications

Microsoft Word
Inspection gauge
Mechanical blueprint interpretation
Measurement-based inspection
Computer operation
Customer communication
New product introduction engineering projects
Team leadership
Quality control statistical data analysis
Statistical Process Control
Parts drawings
Bachelor's degree
Quality standards in production
Biomedical regulatory compliance
ISO 13485
FDA regulations
Customer complaint resolution

Full Job Description

About Us:

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

Job Summary:

Responsible for all areas of Quality Engineering on customer programs. Responsible for working directly with the program management, tooling and manufacturing functions to ensure adequate systems, documentation, inspection methods and tools are used throughout the organization for molding and assembling healthcare products. Understanding customer requirements and implementing appropriate controls, documentation, action plans, and tools necessary to perform quality related tasks at all phases within the process.

Essential Job Duties and Responsibilities:

Create and maintain pFMEA’s, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.
Analyze FAIRs, process and test method validation data before sending to the customer.
Lead customer complaints and CAPA investigations as required.
Manage ECOs, deviations, and documentation updates as required.
Generate and maintain applicable quality system documentation as needed.
Manages activities for handling healthcare products from receiving to shipping.
Assessing and ensuring compliance through training, auditing, and corrective and preventive actions.
Participate in customer audits and provide input to any observations.
Train personnel as required
Review and discuss daily rejects and implement action plans
Make appropriate changes to prevent recurrence of quality related issues.
Make appropriate changes to fixtures or inspection methods and tools as required.
Regular attendance and professionalism.

OTHER POSITION DUTIES:

Make decisions regarding quality related questions as appropriate
Contact customers via verbal/written communication as appropriate
Participate in design reviews as required
Visit customers and suppliers as required
Participate in plant/department meetings and tours as required
Work with Engineering, Manufacturing and Tooling on continuous improvement activities
Maintain cleanliness of work areas and quality measuring equipment
Observe all health and safety requirements and report any unsafe conditions
Other duties as assigned

Essential Qualifications:

Bachelor of Science Degree
5-10 years of experience as a Quality Engineer in the healthcare industry, with New Product Development or New Product Introduction experience required.
Must have experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation
Must be able to read and understand 2D detailed part/article drawings
Must understand the use all quality related inspection equipment
Must have excellent problem solving and mistake proofing skills
Must have computer skills and familiarity with Word and Excel programs
Must have knowledge of SPC
Effective interpersonal and problem-solving skills
New product development experience- minimum of 2 years' experience
Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization

Nice to Have:

Experience with validating large-scale automation
Experience with 21 CFR Part 4 Combination Products

ADA Requirements:

Bend, squat, climb, grasp, reach, lift or otherwise move frequently for extended periods
Lift, move or otherwise transfer up to 50 lbs. frequently, or more occasionally
Walk, stand or otherwise move about continuously
Exposure to machine shop physical hazards including chemicals which may require respiratory protection
Typically sits, grasps items and performs keyboarding for occasional operation of a computer

What SMC has to offer?

Clean, Climate-Controlled Environment
Stable schedule
Paid holiday and PTO
Health, dental, and vision insurance
401(k) retirement savings
Life and disability insurance
Promotional opportunities
Training and career growth programs
Amazing co-workers
Tuition reimbursement
Employee Assistance Program

We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodation during the interview process.

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

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Refine Your Search

validation engineer jobs in devens ma

Quality Engineer- New Product Development

Software Design Quality Engineer

Project Engineer - Plastic Injection Molding

Principal Mechanical Engineer

Mechanical Engineer

Quality Validation Engineer

Manufacturing Engineer - Senior

Lead Software Engineer (AWS)

Sr Engineer, Product

Sr Engineer, Quality Operations

Systems Integration & Test Engineer

Human Factors Engineering - Associate Engineering Fellow

Sr. Test and Validation Engineer 2nd shift - CLEARANCE REQUIRED

Engineer II, Product

Plastics Engineer

Sr Engineer (Software HIT Test)

LTAMDS Production Lead Systems Engineer

Senior Systems Engineer - Air Defense Systems

Senior Controls Engineer

Sr. Test and Validation Engineer - 4th Shift

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