At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
The Senior Manufacturing Engineer is responsible for ensuring products are manufacturable, inspectable, and scalable while meeting quality and regulatory requirements. This role leads design-for-manufacturability (DFM/DFA) efforts, inspection strategy, supplier transfers, and process validations, and partners cross-functionally to manage risk, resolve issues, and drive continuous improvement across internal and external manufacturing operations. The role is critical to supplier readiness, production continuity, and regulatory compliance, including adherence to ZimmerCAS quality standards and applicable global regulations.
Work Location : Bangalore
Work Mode : Hybrid(3 days in office).
How You'll Create Impact
Design for Manufacturability & Inspection
- Participate in design reviews to ensure products are manufacturable and easy to inspect
- Translate engineering design specifications into clear manufacturing and inspection processes
- Develop, review, and validate Inspection Protocols (IP) and related inspection documentation
- Develop and maintain Packaging Specification Sheets (PSS) aligned with quality and regulatory requirements
- Produce clear, accurate technical documentation to support manufacturing and inspection activities
Supplier Transfer & External Manufacturing
- Lead production transfers from internal manufacturing to external suppliers
- Manage supplier-to-supplier transfers while maintaining quality, compliance, and supply continuity
- Collaborate with suppliers to resolve manufacturing, inspection, and quality issues
- Ensure supplier compliance with ZimmerCAS, QMS requirements, and regulatory expectations
- Develop and implement dual-sourcing strategies to reduce supply risk
Validation, Risk & Measurement Systems
- Plan, execute, and support process validations (IQ, OQ, PQ), including special processes
- Conduct and document process risk assessments using pFMEA
- Develop and validate inspection methods in collaboration with suppliers
- Perform and review Test Method Validation (TMV) activities
- Perform and interpret Gage R&R and Measurement System Analysis (MSA)
Quality, NCRs & Root Cause
- Investigate non-conformances (NCRs) and implement effective corrective actions
- Apply root cause analysis techniques (e.g., 5 Whys, Fishbone) to prevent recurrence
- Identify, assess, and mitigate manufacturing and supplier risks
Continuous Improvement & Change Management
- Drive continuous improvement initiatives for existing products and processes
- Lead specification updates and support engineering change activities (ECO/ECN)
- Work cross-functionally with Engineering, Quality, Operations, and Supply Chain teams
What Makes You Stand Out
Manufacturing, Quality & Documentation
- eQMS platforms (e.g., TrackWise, ETQ, MasterControl)
- Inspection Protocols (IP), Packaging Specification Sheets (PSS)
- NCR/CAPA workflows and documentation
- Engineering change systems (ECO/ECN/PLM)
Validation, Risk & Measurement
- IQ/OQ/PQ validation frameworks
- pFMEA, control plans
- TMV, Gage R&R, MSA
- Statistical tools (Excel advanced; Minitab preferred)
Regulatory & Standards
- ISO 13485, 21 CFR Part 820
- Supplier quality management and audit readiness
- Packaging and labeling regulatory requirements (support level)
Manufacturing & Inspection Technologies
- Precision machining, assembly, and inspection methods
- Metrology tools (CMMs, optical measurement, gauges)
- Packaging and sterilization interface knowledge (as applicable)
Your Background
Preferred Qualifications
- 5+ years total experience in medical device manufacturing
- Experience with complex electromechanical or robotic devices
- Experience supporting FDA inspections and supplier audits
- Six Sigma Green/Black Belt, CQE, or equivalent certifications (preferred)
- Experience working with global suppliers and multi-site manufacturing networks
Core Competencies
- Strong DFM/DFA and inspection strategy expertise
- Excellent risk-based thinking and problem-solving skills
- High documentation rigor and audit readiness
- Ability to influence suppliers and cross-functional teams
- Ownership mindset for quality, supply continuity, and patient safety
Education
- Bachelor's degree in Manufacturing, Mechanical, Biomedical, Industrial Engineering, or related field (or equivalent experience)
- 5+ years of experience in manufacturing engineering within a regulated medical device environment
- 2+ years leading supplier transfers, external manufacturing, or contract manufacturing activities
- 2+ years supporting process validation (IQ/OQ/PQ) and inspection method validation
- Demonstrated experience with DFM/DFA, inspection strategy, and quality risk management
Physical Requirements
Travel Expectations
EOE/M/F/Vet/Disability
