Job Details

• Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Lead usability, reliability, testing, verification and validation testing.
• Work closely with regulatory team to drive alignment of project documentation and regulatory requirements. Champions 100% compliance to Company Policy and SOPs. Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
• Support internal and external regulatory audits.
• Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity.
• Analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques and evaluation criteria for obtaining results. Provide quality and compliance input and coaching for new product development activities, such as design changes, product CE marking and safety certification, NCEPs, CAPAs. Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
• Technology development, product design and development, test of materials, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Develops and coaches’ others on engineering documentation.
• Trains and/or provides work direction to less experienced engineers.
• Identify and coordinate activities required to complete the project or task through the team
• Ensure timely completion of activities ensuring policies and practices are followed and accurate documentation is kept
• Effectively lead team ensuring good cross-functional communications and provide input to functional managers on team and team member performance
• Identify, communicate, and manage moderate levels of technical risk
• Delegate and manage tasks among team members as appropriate to their skill level and risk to the project
• Identify and clear barriers or appropriately escalate so the team can progress
• Resolve conflicts with team members and involve functional management as required to ensure timely project completion
• Make occasional presentations to upper management

• Bachelors (or higher) degree in engineering with preference mechanical engineering.
• 10+ years of experience in medical device Quality Engineering.
• Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.
• Sound understanding of medical device regulatory requirements for Class II and III medical devices.
• Project planning – resourcing, timelines, quality and budgets.
• Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
• Preference for candidates with CQE certification or similar training and experience
• Preference for Candidates with ISO 13485 Certified Lead Auditor
• Proficient in project management tools like MS project.
• Experience in GD&T
• Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.
• Preference for Candidates with Process Excellence Green/Black Belt certification

Reference ID - GH/ERC/Lead Engineer - Design Quality Assurance