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Engr 2, Product Development

Brea, CA 92821

Posted: 07/09/2024 Job Category: Other Job Number: 19332

Job Description

R&D Engineer
Location: Brea, CA - Hybrid, expectations are onsite M, T and TH with the availability to be in W & F if need be.
Summary:
  • While maintaining a Customer Focus, responsibilities include (but are not limited to): Execution for Qualification of Medical Devices inclusive of Design Verification, Design Validation and Design Transfer activities.
  • The R&D Engineer II will impact healthcare business groups by engaging in commercialization of new products and design changes for current products through development, qualification and launch phases.
  • The R&D Engineer II contributes to building organizational effectiveness through creating, leveraging and sharing best practices; seeking and providing training; driving technical and workflow innovation.

This requires:
  • Design control understanding and adherence
  • Supporting Design Verification strategy development
  • Supporting Desing Validation strategy development
  • Creating, editing, and interpreting technical drawings
  • Functional Device Testing
  • Testing by Analysis
  • End User Validation Testing
  • Technical writing (protocols, reports, work instructions, presentations, etc.) and effective verbal communication
  • Application of engineering principles for design / analysis
  • Statistical analysis and sample plan development

Innovation
  • Identifies external technologies
  • Identifies critical strengths and weaknesses
  • Nurtures IDR's (Invention Disclosure Records) from infancy
  • Continuous Learning
  • Participates in external activities to enhance the brand recognition of BD by writing papers and generating IP (Intellectual Property)

The R&D Engineer II will demonstrate and cultivate:
  • Accountability: strong and clear accountability for the successful and timely achievement of goals.
  • Ability to assess project / program needs, engage team members, build support, and execute; proactively identify and mitigate risks.
  • Effective Communication:
  • Hold and encourage frequent formal and informal communication within the team and the rest of the organization to ensure dissemination of important information.
  • Recommendations to decision making committees
  • Resolves conflicts within team by facilitating communication
  • Strong interpersonal influence and persuasion skills; situational awareness; ability to persuade or be persuaded based on evidence with or without authority.
  • Inclusive work environment:
  • Promote and leverage diversity to achieve best outcomes.
  • Decisiveness Despite Ambiguity:
  • Developing agility and action orientated when facing change and uncertainty.
  • Autonomously drives projects/deliverables.

Required Qualifications:
  • Bachelors Degree in Mechanical or Biomedical Engineering with a min. of 3+ years of experience in medical device or other regulated industry OR Advanced Degree in Mechanical or Biomedical Engineering.
  • Track record of technical problem solving and effective product development.
  • Design controls expertise for Medical or regulated industry experience.
  • Design Verification experience, (Protocol Generation, Report Writing, Testing Strategies)
  • Proficient in statistical methods / tools
  • Proficient in solid mechanics / mechanics of materials
  • Familiarity with traditional and modern fabrication techniques
  • Knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO14971 and ISO 80369 and collateral standards.

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About Brea, CA

Ready to kickstart your career in the vibrant city of Brea, California? This bustling community in Orange County is a hub of growth and opportunity, making it an ideal location for job seekers looking to thrive. With its proximity to stunning beaches, world-class entertainment venues like the Brea Mall, and renowned art galleries such as the City of Brea Art Gallery, there's no shortage of charm and culture in this picturesque area. Explore our diverse job opportunities and embark on a career journey in a place known for its unique blend of urban amenities and outdoor recreation, making it a standout choice for professionals looking to grow both personally and professionally.