KAYGEN is an emerging leader in providing top talent for technology based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.
Max bill rate to Client is
Interviews - in person
Mandatory minimum 4 days on site M-TH, hours 8 AM - 5 PM / Friday remote but must be flexible to come if needed.
- 3 must have's on the resumes - Design Verification Experience, Protocol / Report Writing Experience, Root Cause Analysis Experience
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 adherenceSupporting Design Verification strategy developmentSupporting Desing Validation strategy developmentCreating, editing, and interpreting technical drawingsFunctional Device TestingTesting by AnalysisEnd User Validation TestingTechnical writing (protocols, reports, work instructions, presentations, etc.) and effective verbal communicationApplication of engineering principles for design / analysisStatistical analysis and sample plan developmentInnovation
Identifies external technologiesIdentifies critical strengths and weaknessesNurtures IDR's (Invention Disclosure Records) from infancyContinuous LearningParticipates in external activities to enhance the brand recognition of Client 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 committeesResolves conflicts within team by facilitating communicationOrganizational 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.Design Verification experience, (Protocol Generation, Report Writing, Testing Strategies)Proficient in statistical methods / toolsProficient in solid mechanics / mechanics of materialsFamiliarity with traditional and modern fabrication techniquesKnowledge 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 similar3 years of post-educational experience in Medical DeviceSought as an SME (Subject Matter Expert) in one or more areas expertiset KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information please visit us at www.kaygen.com.
Benefits with Kaygen
Healthcare Insurance
Vision and Dental Insurance
401(k) Retirement Plan
Free Life Insurance
Vacation Time Off
Sick Time Off
Family Medical Leave (FMLA)
chieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like :
CertificationsMentorship ProgramReferralsFamily and Wellness benefitsContinuous Growth and Career Development
