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Sr. Design Assurance Engineer

Job Description

As a Senior Design Assurance Engineer, you will be responsible for the accurate and independent generation and evaluation of risk management, design history file documentation, and overall quality system compliance. You will ensure compliance with customer and regulatory requirements and assist with the successful transfer of the design to manufacturing. You will plan and lead the execution of risk management on cross-functional product development teams.

Responsibilities

+ Lead risk management for novel and existing medical devices, including risk management plans and reports, hazard analyses, and use, design, and process Failure Mode & Effects Analysis (FMEA).

+ Provide input to development teams in the design of highly complex medical devices.

+ Provide quality insight and leadership on program teams and assist with establishing appropriate build quality controls.

+ Ensure successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.

+ Develop, document, and validate inspection and test methods to support design control, in-process inspection, and final inspection activities.

+ Review, assess, and approve product design milestones and deliverables throughout the product development cycle.

+ Assist with implementing and maintaining a quality system compliant with relevant quality system regulation requirements.

+ Support internal and external audit activities and participate in Quality System continuous improvement activities.

+ Mentor other engineers and support employee development and team building.

Essential Skills

+ Proficiency in medical device design assurance, risk management, validation, and design control.

+ Experience with design verification and FMEAs.

+ Ability to author, revise, and review SOPs.

+ Bachelor's degree in engineering or related field with 3-6 years of relevant work experience.

+ In-depth understanding of FDA Quality System regulations, European Active Implantable & Medical Device Regulations, and relevant medical device principles.

Additional Skills

+ Ability to think creatively and provide guidance on the best path forward for individual programs while maintaining high-quality work and product standards.

+ Experience in Risk Management Planning, DFMEAs, Engineering Verification Planning and Execution, Design Verification Planning and Execution, Measurement Systems Analyses, PFMEAs, Process Verification & Validation Planning and Execution, and Supplier Quality.

Work Environment

This position is based in an office setting, where you will collaborate with a growing medical company in a great location, contributing to high-quality work with diverse teams and customers.

Job Type & Location

This is a Permanent position based out of Providence, Rhode Island

Pay and Benefits

The pay range for this position is $85000.00 - $121000.00/yr.

Medical/dental/vision, PTO, Paid holidays, 401k matching, bonus plan

Workplace Type

This is a hybrid position in Providence,RI.

Application Deadline

This position is anticipated to close on Nov 4, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.