Demo

R&D Engineer - Product Development

A-Line Staffing Solutions
Brea, CA Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 6/2/2025

R&D Engineer II – Product Development

Location : La Brea, CA

Pay Rate : $47.22 / hour

Work Schedule : Mandatory on-site 4 days per week (Monday–Thursday, 8 : 00 AM–5 : 00 PM); Fridays remote, with flexibility to come on-site if needed.

Position Summary

We are seeking a skilled and detail-oriented R&D Engineer II to join our Product Development team. This role supports the commercialization of new medical devices and design changes for existing products through development, qualification, and launch phases. The ideal candidate will bring expertise in Design Verification, Protocol / Report Writing, and Root Cause Analysis to impact healthcare business groups positively.

Key Responsibilities

  • Design Verification and Validation :
  • Develop and support strategies for Design Verification and Design Validation.
  • Conduct functional device testing, testing by analysis, and end-user validation testing.
  • Technical Contribution :
  • Create, edit, and interpret technical drawings.
  • Write and review protocols, reports, work instructions, and presentations.
  • Apply engineering principles for design, analysis, and statistical methods.
  • Innovation :
  • Identify and assess external technologies.
  • Drive invention disclosure records (IDRs) and contribute to intellectual property generation.
  • Participate in external activities to enhance organizational recognition.
  • Leadership and Communication :
  • Demonstrate accountability for timely and successful achievement of goals.
  • Facilitate clear and frequent communication within the team and organization.
  • Provide recommendations to decision-making committees and resolve team conflicts effectively.
  • Organizational Influence :
  • Exhibit strong interpersonal skills and the ability to influence and persuade others.
  • Promote an inclusive work environment and leverage diversity for optimal outcomes.
  • Decisiveness and Agility :
  • Proactively drive projects and deliverables, showing agility in the face of change and uncertainty.

Required Qualifications

  • Education :
  • Bachelor’s Degree in Mechanical or Biomedical Engineering with 3 years of experience in medical devices or other regulated industries.
  • OR an Advanced Degree in Mechanical or Biomedical Engineering.
  • Experience & Skills :
  • Expertise in Design Verification (including protocol generation, report writing, and testing strategies).
  • Strong problem-solving skills and product development experience.
  • Proficiency in statistical methods and solid mechanics / mechanics of materials.
  • Familiarity with traditional and modern fabrication techniques.
  • Knowledge of regulatory standards for medical devices, including FDA QSR 21 CFR 820, ISO 13485, ISO 14971, and ISO 80369.
  • Preferred Qualifications

  • Graduate degree (MS) in Mechanical Engineering, Biomedical Engineering, or a related field.
  • 3 years of post-educational experience in medical device development.
  • Recognized as a Subject Matter Expert (SME) in one or more technical areas.
  • This is an exciting opportunity to make a meaningful impact in the medical device industry by contributing to the development and launch of innovative healthcare products.

    Salary : $47

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