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 Client by writing papers and generating IP (Intellectual Property).
Leadership.
The Research and Development Engineer :
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.
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.
Required Qualifications :
Bachelor's 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.
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.
Preferred Qualifications and 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 expertise.
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