Design Quality Engineer II

Overview

Ensures quality and regulatory compliance of new medical devices throughout design and development.

Key Responsibilities

• risk analysis
• design verification
• quality system
• statistical analysis
• test planning
• inspection plans

Tasks

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

Requirements

• cad
• fmea
• minitab
• regulations
• project management
• risk management

What You Bring

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

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Benefits

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

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms