Engr 3, Product Development - Katalyst Healthcares & Life Sciences

• 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
• 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.
• 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.

Requirements:

• 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.
• Developing agility and action orientated when facing change and uncertainty.
• Autonomously drives projects/deliverables.
• Bachelor's Degree in Mechanical or Biomedical Engineering with a minimum 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.
• Preferred Qualifications and Knowledge:
• 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