What are the responsibilities and job description for the Engineer II - Medical Device Development position at A-Line Staffing Solutions?
Job Description
Job Description
A-Line Staffing is actively searching for Multiple Engineer 2 / Product Development, for a major company located in the Brea, CA surrounding area. This is an exciting opportunity with a client that is looking to move fast for the right candidate. Please contact Brad Zidek at bzidek@alinestaffing.com for immediate consideration! Or call at 412-823-2500.
Location : Brea, CA
Work Schedule : Minimum 4 days on-site (Monday-Thursday), 8 : 00 AM - 5 : 00 PM; Friday remote with flexibility to come on-site as needed.
Overview :
We are seeking an R&D Engineer II to join our team and contribute to the development, qualification, and commercialization of medical devices. The ideal candidate will have expertise in Design Verification, Protocol / Report Writing, and Root Cause Analysis. This role involves working closely with healthcare business groups to bring new products to market and improve existing ones through design verification, validation, and transfer activities. The position requires strong technical skills, a customer-focused mindset, and the ability to work collaboratively with cross-functional teams.
Key Responsibilities :
- Qualification of Medical Devices : Lead design verification, design validation, and design transfer activities for new and existing medical devices.
- Design Control : Ensure adherence to design control processes and standards throughout the product development lifecycle.
- Technical Writing : Develop and review technical documentation including protocols, reports, work instructions, and presentations.
- Design & Analysis : Apply engineering principles for design, testing, and analysis of medical devices, including functional device testing, statistical analysis, and sample plan development.
- Customer Focus : Work closely with business teams to ensure product design meets customer needs and regulatory requirements.
- Innovation : Identify and evaluate external technologies, drive innovation, and contribute to invention disclosure records (IDRs).
- Leadership & Team Collaboration : Take accountability for project deliverables, actively communicate with team members and decision-making committees, and foster an inclusive and collaborative work environment.
- Continuous Learning : Engage in professional development activities and contribute to the advancement of the team’s knowledge and capabilities.
Required Qualifications :
Preferred Qualifications :
Personal Attributes :
