Sr. R&D Engineer - Katalyst Healthcares & Life Sciences

Brea, CA 92821

About the Job

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:
Accountability: strong and clear accountability for the successful and timely achievement of goals.
Ability 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.
Autonomously 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

Source : Katalyst Healthcares & Life Sciences