Job Location: Pune IZiel Healthcare is an Engineering & Regulatory service provider working with global medical device manufacturing. We partner with customers to support them for all aspects of medical device Product Development Life Cycle. Employees are the key to success in our organization. We value our engineers and their skills in furthering the cause of helping lives. Thorough leadership, robust work planning methodology and exceptional customer service are the key enablers of our success. POSITION DESCRIPTION: Provide Engineering Leadership & Project Management Support at IZiel for product development lifecycle of medical devices from Gap Assessment, Design Control, Engineering Documentation, Process Validation (IQ, OQ, PQ, TMV, TMD) to Acquisition Integration Projects. Must successfully manage the customer requirements, oversee all aspects of projects, set deadlines, assign responsibilities, monitor and summarize the progress of project, manage the deliverables and lead IZiel Team in US. Project Management responsibilities include the coordination and completion of projects on time within budget and within scope and thereafter present reports to upper management regarding project status. POSITION RESPONSIBILITIES: • Project Lead would work with IZiel Team & Customer to successfully complete all deliverables within time and budget. • Co-ordinate with IZiel customer to understand their requirements, prioritize the tasks & ensure deliverables are met as per customer needs. • Develop long-term relationship with existing customers & ensure customer satisfaction. • Participate in daily project meetings, drive discussions towards completion for emphasis on following quality systems and rigorous documentation to complete deliverables. • Work with IZiel India Team to execute the project with an Onshore – Offshore Model. • Regular participation in meetings with IZiel India Team & communicate priorities, customer requirements, ensure deliverables are completely understood and set clear expectations. • Conduct Quality Check on deliverables from India Team prior to submitting to the customer. • Provide expertise in Design Control, Process Validation, Risk Management, QMS, DHF Remediation & Documentation to IZiel Team. • Project Lead would develop as well as guide the team to develop Design Control documents to align with the regulatory strategy. • Project Lead would develop Validation Plan & Report, review relevant documents like test plan, requirement traceability matrix, equipment specifications, IQ OQ PQ, Initial Risk Assessment, Test Method Validation, FAT, SAT etc. • Utilize statistics to analyze data, characterize process and perform process validation activities with support from global team. • Create or Upgrade QMS Procedures, Plans in accordance to 21 CFR 820, ISO 13485 etc. • Understand Customer Requirements, Specifications and accordingly make recommendations/ improvements for existing concepts, processes and methodologies. • Resolve queries, customer concerns & drive the project to completion • Develop & present project plan, key issues/ risks to the customers. • Understand opportunities for work outside of IZiel scope and present the customer with plan, methodologies to complete the same by IZiel Team. • Impart knowhow of Six Sigma, Lean Manufacturing, Document Preparation, Requirements Management, Risk Management via training, on the job teaching etc • Must have a good understanding of various guidelines, standards, compliance including but not restricted to cGMP Regulations, 21 CFR, ISO 13485 & ISO 14971. • Perform audit compliances, analyze gaps, shortcomings as per FDA/ISO regulations DESIRED/PREFERRED QUALIFICATIONS: • 10+ years experience in the Medical Device Industry with strong execution abilities. • Team Player with ability to complete projects within timeline and budget • Strong & Clear Communication, Presentation & Coordination Skills (Written & Oral) • Ability to coordinate with customer, manage requirements and successfully complete deliverables. • Attention to detail with task prioritization capabilities (Tactical, Operational & Strategic) • Working understanding of FDA, GMP and ISO 13485. • Experience with basic statistics and/or reliability methodologies and technical writing • Willingness to travel • Bachelor – Engineering Degree or any Advanced Science Degree
We are seeking a highly organized and detail-oriented System Builder, Documentor, and Process Maker to create and maintain efficient workflows, training programs, and process documentation. This role is critical for developing operational systems that allow our teams and clients to operate seamlessly, ensuring consistent and scalable execution. The ideal candidate will have experience in process creation, training program development, and the ability to identify and optimize operational inefficiencies. Job Types: Full-time, Permanent, Fresher Pay: ₹19,097.15 - ₹34,602.91 per month Work Location: In person
Key Responsibilities:* - *Data Entry*: Accurately and efficiently enter data into computer systems or databases from various sources. - *Data Verification*: Verify data accuracy and integrity by comparing it to source documents or other data sets. - *Data Management*: Update and maintain databases with new information, retrieve data as requested, and generate reports. - *Troubleshooting*: Resolve basic technical issues and troubleshoot errors in data entry. - *Collaboration*: Work with other team members to ensure data consistency and accuracy across projects. Job Types: Full-time, Permanent, Fresher Pay: ₹19,433.09 - ₹35,842.99 per month Work Location: In person
About IZiel Healthcare IZiel Healthcare is an Engineering & Regulatory service provider working with global medical device manufacturers. We support customers across the entire medical device product development lifecycle. Our expertise spans process validation, computer system validation, quality assurance, regulatory affairs, and project management. By leveraging our knowledge in medical devices, pharmaceuticals, and biotechnology, we help clients meet industry standards and regulatory requirements, ensuring product safety and effectiveness. We’re Hiring – Design Engineer Location: Pune, Maharashtra Are you passionate about turning concepts into reality? We’re looking for a Design Engineer with expertise in SolidWorks, GD&T, tolerance analysis, and value engineering to work on innovative and impactful projects. What You’ll Do: Work on new product development and equipment design Create 3D models, assemblies, and detailed drawings Ensure compliance with global quality and regulatory standards Collaborate with cross-functional teams to deliver high-quality designs on time What We’re Looking For: ✔0–2 years’ experience in design engineering ✔ Proficiency in 3D CAD (SolidWorks preferred) ✔ Knowledge of plastics & sheet metal manufacturing ✔ Strong problem-solving & communication skills Job Type: Full-time Pay: ₹200,000.00 - ₹300,000.00 per year Work Location: In person