Senior Design Quality Engineer - Medical Devices

Staff Design Quality Engineer

Role: Staff Design Quality Engineer

Location: Kharadi, Pune

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

At Smith+Nephew, as Staff Design Quality Engineer would be reporting into the Quality Department, this role has responsibility for supporting Smith and Nephew QMS and new product development activities for Arthroscopic Enabling Technologies and ENT products as a lead Design Quality Engineer. Technological areas of focus for this position include determining methods, techniques, and evaluation criteria for medical devices containing embedded Software, specifically High Frequency surgical equipment. The Design Quality Engineer will support the completion of Design Control and Risk Management requirements and help to ensure that the finished devices will be safe and effective and conform to applicable regulatory requirements.

What will you be doing?

• (50%) - Provide quality leadership to new product development project (PDP) and/or sustaining project teams as the Quality Engineering representative on projects requiring FDA 510k, CE Mark, and international regulatory approval. Lead efforts to develop verification and validation test methods and procedures to ensure that the appropriate tests are conducted to assure that embedded software, analog and digital electronic circuits, and support hardware used within instrument products meet the required specifications/standards and that the safety and reliability of products are established. Generate/approve/manage software and design verifications, design validations, usability / human factors, reliability testing, process validations, supplier qualifications, test methods, capability studies, and risk management documentation to support the product DHF. Interface with R&D and manufacturing engineers to identify and resolve defects and product quality issues. Lead project cross-functional communication of status and deliverables towards product development milestones and submission filings, including design reviews, risk management, requirements and verification traceability.
• (20%) - Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD / MDR, and NMPA requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.
• (20%) – Provide Quality Management System support for the local site(s) as needed.
• Provide leadership, mentoring, and guidance for other engineers on projects and the Smith + Nephew Quality System

Location: Kharadi, Pune, India

What will you need to be successful?

• Education: B. S. in Electrical, Computer, or Biomedical Engineering or related discipline, M.S. in Engineering preferred
• Licenses/ Certifications: ASQ CQE / CRE (preferred, not required)
• Experience: 8+ years in medical device or related industry with a B.S. degree OR 6+ years in medical device or related industry with a M.S. degree

Competences:

• Understanding the impact of regulatory requirements (eg. GMP’s, ISO 13485, ISO 14971, IEC 62304, IEC 60601, MDD / MDR, and NMPA) on Smith + Nephew’s products
• Need to be able to make sound decisions with attention to details
• Must be able to provide and implement solutions to quality problems
• Ability to plan and schedule multiple projects and tasks
• Excellent oral / written communication skills (GDP knowledge critical)
• Team player
• MS Office and MS Excel software proficiency
• Equipment proficiency preferred with Oscilloscopes, Function Generators, and Digital Multimeters
• Software proficiency preferred in the following:
• Requirement management tool (such as Jama or Cockpit)
• Defect tracking tool (such as Jira)
•  C / Python programming languages

You Unlimited.

We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion + Belonging: - Committed to Welcoming, Celebrating, and Thriving. Learn more about our Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

Other reasons why you will love it here!

• Your Future: Major medical coverage + policy exclusions and insurance non-medical limit. Educational Assistance.

• Work/Life Balance: Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave.

• Your Wellbeing: Parents’/Parents-in-Law’s Insurance (Employer Contribution of 8,000/- annually), Employee Assistance Program, Parental Leave.

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Free Cab Transport Facility for all employees; One-Time Meal provided to all employees as per shift. Night shift allowances.

Experience Level

Senior Level