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Sr. R&D Engineer

3 months ago

Brea, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • While maintaining a Customer Focus, responsibilities include (but are not limited to): Strategy development and Execution for Qualification of Medical Devices inclusive of Design Verification, Design Validation and Design Transfer activities.
  • The R&D Senior Engineer will impact healthcare business groups by driving commercialization of new products and design changes for current products through development, qualification and launch phases.
  • The R&D Senior Engineer contributes to building organizational effectiveness through creating, leveraging and sharing best practices; seeking and providing training; driving technical and workflow innovation.
  • Creating, editing, and interpreting technical drawings
  • Design Verification Strategy Development
  • Functional Device Testing
  • Testing by Analysis
  • Design Validation Strategy Development
  • End User Validation Testing
  • Technical writing (protocols, reports, work instructions, presentations, etc.) and effective verbal communication
  • Expert 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 R&D Senior Engineer will demonstrate and cultivate:
  • ccountability: strong and clear accountability for the successful and timely achievement of goals.
  • bility to assess project / program needs, engage and mentor team members, formulate strategy, build support, and execute; proactively identify and mitigate risks.
  • Proposes strategies to build functional capability.
  • 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.
  • Final 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.
  • utonomously drives projects/deliverables.
Requirements:
  • Bachelor's degree in mechanical or biomedical engineering with a mi. Of 6+ 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.
  • Graduate degree (MS or Phd) in Mechanical Engineering, Biomedical Engineering or similar
  • 8+ years of post-educational experience in Medical Device
  • Sought as an SME (Subject Matter Expert) in one or more areas expertise