engineering
Posted 3 weeks agoStaff Design Quality Engineer
Hybrid
Responsibilities
- 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.
- 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
Requirements
- 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
Benefits
- Other reasons why you will love it here! Your Future: Major medical coverage + policy exclusions and insurance non-medical limit.
- 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.
Contact
- Learn more about our Employee Inclusion Groups on our website ( https://www.smith-nephew.com/ ).
Additional details
- 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.
- 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.
- Interface with R&D and manufacturing engineers to identify and resolve defects and product quality issues.
- 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.
- We believe in crafting the greatest good for society.