Research and Development Engineer

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.
14 days ago