Engineer III, DQA (NPD)

Overview

Engineer III, DQA (NPD) develops, establishes and maintains quality engineering methodologies, systems and practices for new product development, operational, or system/services support, meeting BSC, customer and regulatory requirements.

What you'll do

• Be a part of the core project team and lead quality engineering across the entire development cycle.
• Support the development of CTQs, design input and output documents.
• Support fixture qualification and test method validation.
• Support the development and implementation of design verification and validation plans with the project design lead.
• Support product risk management, usability, reliability and design validation efforts for new product development and design change projects.
• Participate in and implement tools such as Design of Experiments (DOEs), FMEA sessions and risk management, ensuring compliance to CTQs and safety requirements.
• Co-lead stage gate reviews and act as signatory on all PDP document approvals.
• Manage electronic document control and version control on all project-related documents.
• Ensure adherence to quality systems and design assurance SOPs and Boston Scientific's PLCP.
• Support usability, reliability, testing, verification and validation testing, including with internal and local vendors.
• Provide statistical testing and reliability plans.
• Work closely with the regulatory team to align project documentation with regulatory requirements.
• Provide quality and regulatory compliance guidance to product development or design change project teams to assure country-specific compliance for the targeted market.
• Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g., Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).
• Co-lead CAPA efforts and apply systematic problem-solving methodologies (e.g., 5 Whys, Is/Is Not analysis, Six Sigma) to identify, prioritize, communicate and drive resolution of quality issues.
• Devise and support the implementation of quality assurance, process controls, statistical analyses and metrics that assure products meet or exceed internal quality and statutory requirements.
• Participate in ISO 13485 site certification for the R&D center.

What you'll need

• Bachelor's (or higher) degree in engineering.
• 7-9+ years of experience in medical device quality engineering.
• Professional training and certification in Quality Management Systems including ISO 13485, risk management (ISO 14971), design assurance/control, verification and validation/Post Market Surveillance, complaint handling, CAPA/NC, failure investigation and DHF remediation.
• 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 such as design for six sigma, risk management, FMEA and FTA (Fault Tree Analysis).
• Proficient in project management tools such as MS Project.
• Experience in GD&T.
• Well versed in statistical analytical techniques and software tools such as MATLAB and Minitab.

Nice to have

• Preference for a mechanical engineering degree.
• Preference for CQE certification or similar training and experience.

Details

• Location: Pune, Maharashtra, India.
• Requisition ID: 635925.