Senior Quality Engineer - New Product Development

Boston Scientific India Pvt Ltd; Gurugram District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Boston Scientific India Pvt Ltd seeks an experienced Engineer III, DQA (NPD) to lead quality engineering across the full development lifecycle for medical devices. The role focuses on CTQ development, design input/output, and qualification activities, with strong emphasis on risk management, usability, and design validation for new product development and changes.

The successful candidate will drive quality deliverables, support regulatory alignment, and mentor team members while maintaining

Qualifications

• Bachelor's (or higher) in engineering with preference mechanical engineering.
• 7-9+ years of experience in medical device quality engineering.
• Professional training and certification in Quality Management Systems incl. ISO 13485, ISO 14971; CQE preferred.
• Experience with design assurance/control, verification and validation, Post Market Surveillance.
• Proficient in project planning, resourcing, timelines, budgets.

Responsibilities

• Lead quality engineering across the entire development cycle.
• Support CTQ's, design input/output documents.
• Support fixture qualification and test method validation.
• Develop and implement design verification/validation plans with project lead.
• Lead product risk management, usability, reliability and design validation for new products and changes.
• Lead and participate in DOE, FMEA, risk management activities; ensure CTQ & safety compliance.
• Co-lead stage gate reviews and document approvals; manage document control.
• Ensure adherence to quality systems and SOPs including PLCP.
• Coordinate with regulatory team to align project documentation with regulatory requirements.
• Provide guidance on country-specific regulatory compliance for distribution.

Skills

Quality engineering

Design of Experiments

FMEA

CAPA

Regulatory compliance

CTQ development

DOE implementation

Statistical analysis

MS Project

GD&T

V&V planning

Vendor interaction

Education

Bachelor's or higher in engineering (mechanical preferred)

Tools

MATLAB

MINITAB

MS Project

GD&T

Job description

Engineer III, DQA (NPD)

Additional Locations: N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. Develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

Key Responsibilities

• Be a part of core project team and lead the quality engineering across the entire development cycle.
• Support the development of CTQ's, design input and output documents.
• Support the fixture qualification and test method validation.
• Support the development and implementation of design verification and validation plans with project design lead.
• Support product risk management, usability, reliability and design validation efforts for new product development and design change projects.
• Participate and implement tools like Design of Experiments (DOE's), FMEA sessions, Risk Management and ensure compliance to CTQ's and safety requirements.
• Responsible for co-leading stage gate reviews and signatory on all PDP document approvals Manage electronic document control and version control on all project related documents.
• Ensure adherence to the quality systems and design assurance SOPs and Boston Scientific's PLCP.
• Support usability, reliability, testing, verification and validation testing - internal and local vendors.
• Provide statistical testing and reliability plans.
• Work closely with regulatory team to drive alignment of project documentation and regulatory requirements.
• Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
• 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 sound, systematic problem-solving methodologies identifying, prioritising, communicating, and driving resolution of quality issues (e.g., 5 why's analysis Is-Is Not analysis, and Six Sigma problem solving methodologies).
• 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.
• Participate in ISO13485 site certification for the R&D center.
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanliness).
• Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
• Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
• Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
• Is familiar with the internal auditing process.

Academic Qualification and Experience

• Bachelors (or higher) degree in engineering with preference mechanical 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 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 like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
• Preference for candidates with CQE certification or similar training and experience.
• 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.

Requisition ID: 635920

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.

Learn more at www.bostonscientific.com and follow us on LinkedIn . Experience Level Senior Level