R&D Engineer

Actalent; Littleton (CO); On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

401(k) Retirement Plan

Life Insurance

Health Spending Account (HSA)

Paid Time Off

Job summary

Actalent is seeking an engineer to lead remediation design activities for medical devices, ensuring compliance with FDA and ISO standards. You will collaborate cross-functionally to execute verification and validation testing and manage product risk assessments.

The role requires a strong background in FDA design controls, risk management (FMEA), and hands-on SolidWorks expertise, with a focus on robust documentation and design history files.

Qualifications

• Bachelor's or Master's in Mechanical, Biomedical, or Electrical Engineering with R&D experience in the medical device industry.
• Proven expertise in FDA design controls, risk management tools like FMEA, and proficiency in SolidWorks.

Responsibilities

• Lead remediation design activities and technical documentation to ensure compliance with FDA and ISO standards.
• Collaborate cross-functionally to execute verification and validation testing.
• Manage product risk assessments.

Skills

FDA Design Controls

Medical Device Design

Risk Management

FMEA

Verification and Validation

Technical Writing

ISO Standards

IEC Standards

CAPA

Product Lifecycle Management

Engineering Studies

Regulatory Compliance

Design History Files

Fault-tree Analysis

Education

Bachelor's or Master's in Mechanical, Biomedical, or Electrical Engineering

Tools

SolidWorks

Windchill

Job description

Lead remediation design activities and technical documentation for medical devices to ensure compliance with FDA and ISO standards. Collaborate cross-functionally to execute verification and validation testing and manage product risk assessments.

Requirements:

Requires a Bachelor's or Master's degree in Mechanical, Biomedical, or Electrical Engineering with R&D experience in the medical device industry. Must have proven expertise in FDA design controls, risk management tools like FMEA, and proficiency in SolidWorks.

Key Skills:

• FDA Design Controls
• Medical Device Design
• Risk Management
• FMEA
• Verification and Validation
• Technical Writing
• SolidWorks
• Windchill
• ISO Standards
• IEC Standards
• CAPA
• Design History Files
• Fault-tree Analysis
• Product Lifecycle Management
• Engineering Studies
• Regulatory Compliance

Benefits:

• Medical
• Dental
• Vision
• Critical Illness
• Accident
• Hospital
• 401(k) Retirement Plan
• Life Insurance
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Paid Time Off