Design Quality Engineer II

Description

• Develop, review, and approve inspection plans, routers, and product drawings for new products.
• Participate in the collection of initial market feedback and address early concerns.
• Participate in design reviews by identifying product risks and ensuring effective mitigation strategies.
• Promote efficient testing practices and support the development of manufacturing processes for new products.
• Support the definition of design verification and validation test requirements.
• Engage in design, development, manufacturing, and risk management activities for new product development projects.
• Maintain quality system processes by identifying and correcting deficiencies in procedures and practices.
• Evaluate predicate products for relevant quality issues impacting new development projects.
• Utilize statistical analysis and problem-solving techniques to establish product acceptance limits and resolve quality issues.
• Support product design transfers to manufacturing facilities.
• Lead risk management activities by developing risk management plans and conducting risk reviews.
• Complete final design verification and validation reports with statistical and graphical support.
• Develop quality assurance documentation to support new product development and regulatory submissions.
• Analyze and define critical quality attributes through risk analysis techniques.

Requirements

• 4-5 brief bullet points highlighting technical qualifications
• Experience interacting with regulatory agencies such as FDA, MoH, TUV.
• Strong interpersonal, written, oral communication, and negotiation skills.
• Critical thinking and problem-solving skills.
• Ability to work cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
• Demonstrated ability to manage and complete projects in a matrix organization.
• Strong knowledge of Quality Concepts like CAPA, Audits, Statistics.
• Ability to read and interpret CAD drawings.
• Experience in compliance risk situations.
• Proficiency with computer literacy, including analysis programs like Mini-Tab.
• Experience with the medical device product development lifecycle, including risk management and design/process verification and validation.
• 2-3 professional references
• Applied knowledge of Advanced Quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing.
• Demonstrated ability to advocate for product excellence and quality.
• Thorough knowledge of US and International Medical Device Regulations.
• Strong project management skills and the ability to manage multiple tasks simultaneously.
• Analytical skills and the ability to work independently.

Benefits

• Health Spending Account (HSA)
• Employee Assistance Program
• Transportation benefits
• Critical Illness, Accident, and Hospital
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Short and long-term disability
• Medical, dental & vision
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

Training + Development

Interview process

Visa Sponsorship

Security clearance