Monster

Design Verification Engineer

A-Line Staffing Solutions

Brea, CA

JOB DETAILS
SKILLS
Analysis Skills, Best Practices, Biomedical Engineering, Code of Federal Regulations, Communication Skills, Customer Relations, Design Verification, Develop and Maintain Customers, FDA (Food and Drug Administration), Functional Testing, Healthcare, ISO (International Organization for Standardization), Intellectual Property (IP), Invention Disclosures, Leadership, Mechanical Engineering, Medical Equipment, Organizational Development/Management, Presentation/Verbal Skills, Problem Solving Skills, Product Design, Product Development, Product/Service Launch, Program Evaluation, Project Evaluation, Quality System Requirements (QSR), Regulations, Reporting Skills, Research & Development (R&D), Risk Analysis, Risk Management, Root Cause Analysis, Software Engineering, Solid Mechanics, Statistics, Strategic Planning, Technical Drawing, Technical Editing, Technical Writing, Technical/Engineering Design, Test Strategy, Time Management, Training/Teaching, Validation Testing, Verification Engineering, Writing Skills
LOCATION
Brea, CA
POSTED
30 days ago

We are looking for a Design Verification Engineer in the Brea, CA Area.

Pay: $47.22

Schedule:
Mandatory minimum 4 days on site M-TH, hours 8 AM – 5 PM / Friday remote but must be flexible to come if needed.

JOB DESCRIPTION:

• 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 adherence
• Supporting Design Verification strategy development
• Supporting Desing 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.
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 / 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

Please click to apply now or reach out to Chin Yang at A-Line Staffing

. 586-323-4194
|
cyang@alinestaffing.com

About the Company

A

A-Line Staffing Solutions

A-Line Staffing Solutions is a premier staffing company that supplies professionals to the Healthcare, Insurance, Pharmaceutical, and Information Technology industries. Founded in 2004, A-Line Staffing Solutions has been a leader in matching talented individuals to the jobs that our clients NEED to fill. We are experts at offering creative staffing solutions to employers, and we are hiring every day. A-Line Staffing can offer short-term, long-term and direct-hire opportunities to professionals across the United States. We hire only the most qualified and talented individuals in the country. Our recruiting, selection and stringent screening processes have strengthened our reputation for delivering quality customer service and unbeatable talent. For our commissioned clients, A-Line Staffing closely follows the standards and practices established by The Joint Commission. For all of our clients and employees, our commitment to continual improvement combined with a strict code of ethics provides an atmosphere of respect and unparalleled professionalism. To find out how A-Line Staffing Solutions can share our talent with you, please contact us today. We are eager to include you among our most valued and satisfied clients. If you are a professional and would like to learn more about open opportunities in your area, please contact us today. We are always searching for talented and enthusiastic professionals

COMPANY SIZE
1,000 to 1,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2004
WEBSITE
http://www.alinestaffing.com/