Top 1301 Validation engineer Jobs in Waltham, Ma

R&D Manager – Insulin Pump
Dyme Medical —Marlborough, MA
- $140,000 - $160,000 a year
- Full-time
- Bachelor's degree
- In-person
- Senior level
- Health insurance
- Dental insurance
Quick Apply
Senior Optical Engineer
AVAVA, Inc. —Waltham, MA
- From $150,000 a year
- Full-time
- Background check
- 6 years
- Analysis skills
- Health savings account
- Disability insurance
Quick Apply
Senior Ai Engineer
Health Data Analytics Institute —Dedham, MA
- $160,367 - $185,457 a year
- Full-time
- Hybrid work
- 7 years
- AWS
- APIs
- Health savings account
- Health insurance
Quick Apply
7d
Autonomy Software Engineer
MORSE Corp —Cambridge, MA
- $90,000 - $210,000 a year
- Computer science
- Bachelor of Science
- Analysis skills
Quick Apply
Sr Test Engineer
Draeger Medical Systems, Inc. —Andover, MA
- $106,000 - $127,000 a year
- Microsoft Access
- 5 years
- Master's degree
- Free parking
- Paid holidays
3d
Lead Computer Systems Validation Engineer I (Clinical & R&D)
Alkermes, Inc. —Waltham, MA
- Full-time
- Psychiatry
- Bachelor's degree
- Neurology
11d
Design Assurance Engineer
Entegee —Southborough, MA
- $90,000 - $100,000 a year
- Full-time
- Engineering
- Mid-level
- 3 years
- Commuter assistance
- Disability insurance
Quick Apply
4d
Design Assurance Engineer / Class II Medical Devices
Motion Recruitment —Marlborough, MA
- Full-time
- Microsoft Word
- Microsoft Excel
- Engineering
- Health savings account
- Health insurance
8d
INGENYX- Design Quality Assurance Engineer II
Teleflex —Mansfield, MA
- $87,400 - $131,100 a year
- Engineering
- Mid-level
- Analysis skills
- Disability insurance
- Health insurance
Quick Apply
Design Assurance Engineer / Medical Devices
Motion Recruitment —Marlborough, MA
- Full-time
- Microsoft Excel
- Mid-level
- 3 years
4d
Test and Validation Engineer II - 4th Shift
Raytheon —Andover, MA
- $68,900 - $131,100 a year
- 12 hour shift
- Mid-level
- 2 years
- Paid holidays
- Disability insurance
Sr. Validation Engineer I
QABASA Professionals —Woburn, MA
- Email
- Mid-level
- Master's degree
- Databases
- Paid training
- Relocation assistance
Validation Engineer
Syner-G —Boston, MA
- Mid-level
- Residential
- 3 years
- Paid holidays
- Paid time off
Lab Support Engineer
Katalyst Healthcares & Life Sciences —Waltham, MA
- Contract
- Computer science
- Computer Science
- Mid-level
Quick Apply
Software Test Engineer - Medical Device Integration (Bedford, MA)
Philips —Bedford, MA
- $115,000 - $182,000 a year
- Full-time
- Computer Science
- Mid-level
- Office
- Health savings account
- Employee stock purchase plan
6466 - Lab IT Support Engineer (Win11 upgrade) / Senior Validation Engineer
Verista, Inc. —Cambridge, MA
- $83.70 an hour
- Contract
- Laboratory experience
- Mid-level
- Windows
- Commuter assistance
- Paid parental leave
Quick Apply
Sr. Validation Engineer I (Pharma)
QABASA Professionals —Woburn, MA
- Email
- Mid-level
- Master's degree
- Databases
- Paid training
- Relocation assistance
Quality Engineer
Dassault Systèmes —Waltham, MA
- $116,000 - $140,000 a year
- Hybrid work
- System design
- Mid-level
- 3 years
- Paid holidays
- Disability insurance
Staff Validation Engineer
Drägerwerk AG & Co. KGaA —Andover, MA
- $135,325 a year
- Hybrid work
- 3 years
- Travel
- Mentoring
- Free parking
- Paid holidays
5d
Validation Engineers
Biometrix —Prides Crossing, MA
- Customer service
- Bachelor of Science
- Engineering
- Health insurance
- Dental insurance

I want to receive the latest job alert for validation engineer in waltham, ma

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

validation engineer jobs near waltham, ma

R&D Manager – Insulin Pump

Dyme Medical
Marlborough, MA

Quick Apply

Job Details

Full-time
$140,000 - $160,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Developing medical devices
Rapid prototyping
FDA submissions
Managing medical device teams
Communication with suppliers
Teamwork
New product introduction engineering projects
Project engineering
Quality management standards in production
Requirements specification
Electro-mechanical components
Accreditation standards (regulatory compliance area)
Requirements design
Collaboration with product development teams
Bachelor's degree in engineering
Managing engineering teams
Bachelor's degree
Quality risk management
Quality control documentation
Requirements analysis
Design engineering
Leading team collaboration initiatives
Regulatory/legal compliance standards in production
Collaboration with manufacturing teams
Design controls
Biomedical regulatory compliance
Regulatory submissions
Diabetes care
Research & development
Mechanical product validation projects

Full Job Description

Job Overview

We're looking for an experienced engineer to provide system-level technical leadership for the development of a next-generation insulin pump. You'll lead cross-functional product development spanning requirements, architecture, risk management, verification and validation, and design transfer in a regulated medical device environment, and you'll get to see it through to real patients.

This is a hands-on senior individual contributor role, not a people-management position. The ideal candidate pairs deep medical device expertise with strong technical judgment, project management, and the drive to own outcomes and push work to closure.

Key Responsibilities

Serve as the technical lead for cross-functional development of the Dyme Insulin Pump.
Provide day-to-day technical leadership across R&D to align priorities, schedule, and execution.
Contribute to product requirements, system specifications, architecture inputs, and technical documentation.
Drive the technical planning behind key product objectives, including V&V strategy, test planning, and design readiness.
Develop project plans, technical schedules, and task priorities to hit development milestones and deliverables.
Coordinate technical execution across the engineering team and support activity at external development partners.
Contribute directly as a hands-on engineer by owning individual technical tasks and deliverables.
Partner with Manufacturing Engineering on design-for-manufacturability and work instructions.
Collaborate with Engineering and Quality to maintain design control documentation, including the DHF and DMR.
Contribute to risk management activities, including FMEA, hazard analysis, risk assessment, and mitigation planning.
Thrive in a startup-style environment that rewards initiative, flexibility, and cross-functional collaboration.

Regulatory and Standards Knowledge

Working knowledge of, and hands-on experience applying, the regulations and standards most relevant to insulin pump and connected medical device development:

FDA Quality System Regulation / QMSR expectations (21 CFR Part 820) and practical application of design controls.
FDA development and submission expectations for Class II devices, including experience supporting 510(k) submissions.
ISO 14971 for risk management across design, verification, manufacturing, and post-market.
Traceability, verification, validation, and design transfer needed 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.
Significant medical device development experience with 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 grasp of design controls, requirements development, risk management, V&V, and regulated product documentation.
Experience working with manufacturing, quality, regulatory, suppliers, contract manufacturers, and external development partners.
Strong written and verbal communication, with the ability to influence cross-functional teams and drive technical closure.
Creativity, initiative, and strong technical problem-solving; patent or invention history is a plus.
Comfort leading through influence, without formal direct reports.

Pay: $140,000.00 - $160,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Education:

Bachelor's (Preferred)

Experience:

Engineering: 5 years (Required)

Work Location: In person

Quick Apply

Refine Your Search

validation engineer jobs in waltham, ma

R&D Manager – Insulin Pump

Senior Optical Engineer

Senior Ai Engineer

Autonomy Software Engineer

Sr Test Engineer

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Design Assurance Engineer

Design Assurance Engineer / Class II Medical Devices

INGENYX- Design Quality Assurance Engineer II

Design Assurance Engineer / Medical Devices

Test and Validation Engineer II - 4th Shift

Sr. Validation Engineer I

Validation Engineer

Lab Support Engineer

Software Test Engineer - Medical Device Integration (Bedford, MA)

6466 - Lab IT Support Engineer (Win11 upgrade) / Senior Validation Engineer

Sr. Validation Engineer I (Pharma)

Quality Engineer

Staff Validation Engineer

Validation Engineers

I want to receive the latest job alert for validation engineer in waltham, ma

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected