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Research and Development Engineer

3 months ago

Brea, United States Cynet Systems Full time
Job Description:

Pay Range $41.42hr - $46.42hr
  • Design control understanding and adherence.
  • Supporting Design Verification strategy development.
  • Supporting Design 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 by writing papers and generating IP (Intellectual Property).
Leadership:
  • 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 the team by facilitating communication.
Organizational Influence:
  • 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.
Qualifications:
  • Bachelor's Degree in Mechanical or Biomedical Engineering with a 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.
Knowledge:
  • Graduate degree (MS) in Mechanical Engineering, Biomedical Engineering or similar.
  • 3+ years of post-educational experience in Medical Device.
  • Sought as an SME (Subject Matter Expert) in one or more areas of expertise.