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Research And Development Engineer

4 months ago

Franklin Lakes, United States Stellar Consulting Solutions, LLC Full time

Description:


Hybrid, expectations are onsite MT and TH with the availability to be in WF if need be.


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 Designing 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)


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 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.


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.
  • 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.


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