Top 986 validation engineer Jobs in marlborough, ma

R&D Engineering Manager
Dyme Medical —Marlborough, MA
- $150,000 - $170,000 a year
- Full-time
- Management
- Bachelor's degree
- Product management
- Paid training
- Relocation assistance
Quick Apply
R&D Robotics Assembly Technician
BlackTree Technical Group —Waltham, MA
- $32 an hour
- Full-time
- CAD
- Mid-level
- High school diploma or GED
Quick Apply
Principal Pricing Data Engineer
Waters Corporation —Milford, MA
- $112,500 - $187,500 a year
- Computer Science
- Office
- 8 years
Raytheon Full Time 2026 - Digital Electronics Electrical Engineer II
Raytheon —Marlborough, MA
- $68,900 - $131,100 a year
- Full-time
- CAD
- Analysis skills
- Electrical Engineering
- Paid holidays
- Disability insurance
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
Quick Apply
Graphics Engineer
Krevera —Waltham, MA
- $110,000 - $135,000 a year
- Full-time
- Mid-level
- Math
- US work authorization
- Health insurance
- Dental insurance
Quick Apply
Electrical Engineer
MagiQ Technologies, Inc. —Somerville, MA
- Full-time
- Hybrid work
- Microsoft Office
- Master's degree
- US work authorization
- Health savings account
- Health insurance
Quick Apply
ML ops Engineer (local candidates only)
Health Data Analytics Institute —Dedham, MA
- $125,453 - $160,567 a year
- Full-time
- Hybrid work
- Computer science
- Azure
- Computer Science
- Health savings account
- Health insurance
Quick Apply
4d
Senior Network Engineer
Astrion —Hanscom AFB, MA
- $155,000 - $175,000 a year
- Full-time
- Engineering
- 11+ years
- Office
3d
Lead Software Engineer (AWS)
Kingfisher Company Inc. —Lowell, MA
- $80,000 - $120,000 a year
- Full-time
- 7 years
- Computer Science
- Office
Quick Apply
7d
Regional Lead Quality Engineer
CSL Behring —Waltham, MA
- $143,000 - $169,000 a year
- Full-time
- Team management
- Travel
- Organizational skills
Senior Systems Engineer
Portal Instruments —Cambridge, MA
- $120,000 - $160,000 a year
- Email
- 5 years
- C++
- Bachelor's degree
- Health savings account
- Health insurance
Quick Apply
Senior Embedded Firmware Engineer
Portal Instruments —Cambridge, MA
- From $140,000 a year
- Full-time
- Computer Science
- C++
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
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
Quick Apply
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
Quick Apply
Mechanical Engineer
FootBridge —Chelmsford, MA
- $35 - $50 an hour
- Full-time
- Mid-level
- Analysis skills
- 2 years
- Health insurance
- Dental insurance
Quick Apply
7d
Clinical Engineer
Getinge —Waltham, MA
- $75,000 - $90,000 a year
- Full-time
- Mid-level
- 3 years
- Master's degree
- Commuter assistance
- Disability insurance
9d
Principal Mechanical Engineer
Brooksource —Boxborough, MA
- $65 - $80 an hour
- Contract
- 5 years
- Bachelor's degree
- Mentoring
- Health savings account
- Paid holidays
Quick Apply
Senior AI Agent Engineer
GE Vernova —Cambridge, MA
- $113,200 - $188,800 a year
- Full-time
- 18 years or older
- Computer science
- Computer Science
- Paid parental leave
- Paid holidays
Process Engineer
System One —Waltham, MA
- $45 - $51 an hour
- Contract
- Assembly
- Analysis skills
- Math
- Health insurance
- Dental insurance
Quick Apply
7d

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validation engineer jobs near marlborough, ma

R&D Engineering Manager

Dyme Medical
Marlborough, MA

Quick Apply

Job Details

Full-time
$150,000 - $170,000 a year

Benefits

Paid training
Stock options
Relocation assistance
Health insurance
Dental insurance
401(k)
Paid time off
On-the-job training
Flexible schedule

Qualifications

Developing medical devices
FDA submissions
Managing medical device teams
Communication with suppliers
Teamwork
New product introduction engineering projects
Project engineering
Quality management standards in production
Management
Accreditation standards (regulatory compliance area)
Requirements design
Electrical engineering
Collaboration with product development teams
Bachelor’s degree in engineering
Managing engineering teams
Bachelor's degree
Quality risk management
Requirements analysis
Medical device design
Requirements management
Leading team collaboration initiatives
Collaboration with manufacturing teams
Design controls
Biomedical regulatory compliance
Regulatory submissions
Quality systems
Test validation method
Research & development
Mechanical product validation projects
Mechanical knowledge

Full Job Description

Job Overview
We are seeking an experienced R&D Manager to provide system-level technical leadership for the development of a next-generation Insulin Pump. This individual will lead cross-functional product development activities spanning requirements, architecture, risk management, verification and validation, and design transfer in a regulated medical device environment.

This is a hands-on senior individual contributor role, not a formal people-management position. The ideal candidate combines deep medical device expertise with strong technical judgment, project management, execution skills, and technical leadership.

Key Responsibilities

· Serve as the technical lead for the cross-functional development of the Dyme Insulin Pump.

· Provide day-to-day technical leadership across R&D activities to align priorities, schedule, and execution activities.

· Participate in development of product requirements, system specifications, architecture inputs, and technical documentation.

· Drive technical planning needed to achieve key product objectives, including verification and validation strategy, test planning, and design readiness.

· Develop project plans, technical schedules, and task priorities in support of development milestones and deliverables.

· Coordinate technical execution of engineering team and support activity at external development partners.

· Contribute directly as a hands-on engineer by completing individual technical tasks and deliverables.

· Partner with Manufacturing Engineering to support design-for-manufacturability goals and development of work instructions.

· Collaborate with Engineering and Quality to maintain design control documentation, including the Design History File (DHF) and Device Master Record (DMR).

· Contribute to product risk management activities, including FMEA, hazard analysis, risk assessment, and mitigation planning.

· Work effectively in a startup-style environment that requires initiative, flexibility, and strong cross-functional collaboration.

Regulatory and Standards Knowledge

The ideal candidate should have working knowledge of, and experience applying, the regulations and standards most relevant to insulin pump and connected medical device development, including:

· FDA Quality System Regulation / Quality Management System Regulation expectations (21 CFR Part 820) and practical application of design controls in a regulated development environment.

· FDA development and submission expectations applicable to Class II medical devices, including experience supporting 510(k) submissions.

· ISO 14971 for medical device risk management across design, verification, manufacturing, and post-market considerations.

· Traceability, verification, validation, and design transfer expectations required to support DHF and DMR readiness.

Required Qualifications

· Bachelor's degree in Mechanical Engineering or a related engineering discipline; advanced degree preferred.

· Strong mechanical engineering background, with working knowledge of electrical and software systems in an integrated product environment.

· Significant experience in medical device development, involving Class II electromechanical software-enabled devices.

· Direct experience supporting products through the 510(k) process.

· Demonstrated experience leading system-level product development in a regulated environment.

· Strong understanding of design controls, requirements development, risk management, verification and validation, and regulated product documentation.

· Experience collaborating with manufacturing, quality, regulatory, suppliers, contract manufacturers, and external development partners.

· Strong written and verbal communication skills, with the ability to influence cross-functional teams and drive technical closure.

· Demonstrated creativity, innovation, and technical problem-solving; patent or invention history is a plus.

· Comfort leading through influence without formal direct-report management.

Pay: $150,000.00 - $170,000.00 per year

Benefits:

401(k)
Dental insurance
Flexible schedule
Health insurance
On-the-job training
Paid time off
Relocation assistance
Stock options

Education:

Bachelor's (Preferred)

Experience:

Medical Device: 10 years (Preferred)

Work Location: In person

Quick Apply

Refine Your Search

validation engineer jobs in marlborough, ma

R&D Engineering Manager

R&D Robotics Assembly Technician

Principal Pricing Data Engineer

Raytheon Full Time 2026 - Digital Electronics Electrical Engineer II

Manufacturing Engineer - Senior

Graphics Engineer

Electrical Engineer

ML ops Engineer (local candidates only)

Senior Network Engineer

Lead Software Engineer (AWS)

Regional Lead Quality Engineer

Senior Systems Engineer

Senior Embedded Firmware Engineer

Quality Engineer- New Product Development

Systems Integration & Test Engineer

Mechanical Engineer

Clinical Engineer

Principal Mechanical Engineer

Senior AI Agent Engineer

Process Engineer

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