98 Dmf Jobs - Page 4

Role & responsibilities 1. Preparation of DMFs for regulated (US, EU) & ROW markets. 2. Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs. 3. Preparation of response to deficiencies from regulatory authorities & customers. 4. Review of the data for DMF preparation received from mfg. site and R&D and ensuring required corrections. 5. Coordination with cross functional teams for data / documents. Review of the DMFs & other submissions prepared by the team. Preferred candidate profile 1. Candidate should be M.Sc. Chemistry with 6-8 years experience OR B.Sc. - Chemistry with 8 years plus relevant work experience in a reputed pharma industry, preferably in API RA. 2. Should possess good knowledge of ICH guidelines and regional regulatory requirements for US, EU, Brazil & other ROW markets. 3. Should have individually handled DMF & deficiency response submissions. Should have strong analytical & interpersonal communication skills.

Dear Candidate, We have a Job Opening for FLO-ETP /WTP in Reputed Industry at Harihar, Karnataka. Requirement Details: Location : Harihar, Karnataka Designation: Assistant Manager/Engineer Experience: 3 to 7 Years Qualification: BE /B. Tech Chemical Engineering Regular Expected Notice Period : Immediate to 30 days Responsibilities: Ensure supply of Filter, DM and Soft water to Pulp plant, fibre plant, Energy Centre and Colony Achieving First Pass Yield (FPY) and Up time (UT) Ensure treatment of effluent If you are interested, kindly share your updated CV to cg12@convate.com with below details. Kindly fill the below details: 1. Reason for job change: 2. Current Salary: 3. Expected Salary: 4. Joining Time needed Request you to kindly refer any of your friends or colleagues relevant and interested to the opportunity shared. About Convate Consultancy Recruitment Firm: Estd in 2004, Convate (team of 60 recruiters) is a leading International Recruitment Company having operations in Bangalore and Dubai. We specialize in the recruitment of IT/Healthcare/Engineering in India and the Middle East. Convate provides a learning-based work culture with a strong opportunity to grow in the years to come. Thanks and Regards, Snigdha Jha Recruitment Specialist Cg12@convate.com 9172215407 Convate Consultancy Services Pvt Ltd

Accountable to develop, implement and communicate the regulatory strategies to support registration activities for all Products for all global markets such as US, EU, Canada, Gulf and ROW Market. Lead, manage and develop leading edge regulatory strategies leading to successful regulatory filings and approvals for Generics for Global markets. implement changes required to comply with new regulatory requirements and to effectively lead and direct the creation of required data packages and facilitate knowledge for drug development. Collaborate with development and other cross functional teams during the product development activities to provide appropriate CMC as well as regulatory strategies. critical regulatory requirements to meet the quality submission and timely approvals. Responsible for all queries received from Agency or customers. Post-approval changes and Post approval compliance. communicate critical aspects of ongoing project activities and influence internal/external stakeholders to meet the regulatory requirements.

Accountable to develop, implement and communicate the regulatory strategies to support registration activities for all Products for all global markets such as US, EU, Canada, Gulf and ROW Market. successful regulatory filings and approvals for Generics for Global markets. implement changes required to comply with new regulatory requirements and to effectively lead and direct the creation of required facilitate knowledge for drug development. Collaborate with development and other cross functional teams during the product development critical regulatory requirements to meet the quality submission and timely approvals Responsible for all queries received from Agency or customers Post-approval changes and Post approval compliance communicate critical aspects of ongoing project activities and influence internal/external stakeholders to meet the regulatory requirements.

Roles and Responsibilities Manage ANDAs (Abbreviated New Drug Applications) for US market approval. Coordinate with DMF (Dossier Management Facility) team for dossier compilation and submission. Prepare dossiers, variations, renewals, and amendments according to FDA guidelines. Ensure timely review of documents by internal teams and external agencies. Maintain accurate records of all regulatory correspondences. Desired Candidate Profile MS/M.Sc(Science) or M.Pharma degree from a recognized institution. Strong understanding of formulation research development principles. Excellent communication skills with ability to work effectively with cross-functional teams. 0-3 years of experience in Regulatory Affairs - Formulations with expertise in drug regulatory affairs.

Roles and Responsibilities Prepare dossiers for DMF (Dossier Management Facility) submissions to US FDA, including eCTD structure preparation, data compilation, and review. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Review and compile technical documentation for various global markets, ensuring compliance with regulations. Manage change controls, variation applications, renewals, variations, extensions, and post-approval changes. Provide guidance on regulatory requirements to internal stakeholders. Desired Candidate Profile 6-10 years of experience in Regulatory Affairs or related field (API industry preferred). MS/M.Sc(Science) in Chemistry or equivalent qualification. Strong understanding of emerging markets' regulations (US FDA). Excellent communication skills with ability to work effectively across functions.

Preparation & implementation of SOPs related to the concerned department & Specification Handles the Regulatory & Customer audit and its compliance Responsible for ensuring that all necessary documentation is completed accurately Required Candidate profile Must to have exp into DMF Filling Good in Audit Must be from API

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master’s degree OR Bachelor’s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate’s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Knowledge on Regulatory guidelines for API & Finished product registration. Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets. Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling of customer and MOH queries. Coordination with cross-functional teams & Reviewing of Documents (Specification, MOA, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Should have hand on experience in handling ODLS, FSSAI, Sugam Portal for Licensing of Drug & Food Products. Prior knowledge on Administrative document applications (COPP, GMP, Free sale and Import License). Registration information management system updates on regular basis. Requirements Bachelors/Masters degree in Biotechnology/ Microbiology/ Pharmacy/ Regulatory Affairs. 1-4 Years of experience as Regulatory Affairs Executive in Pharmaceuticals. Interpersonal and communication skills Planning and organizing skills

To prepare Standard Operating Procedures of all departments. To review batch manufacturing records protocols and reports of all Active Pharmaceuticals Ingredients and Intermediates to support DMF / FILING. Follow quality assurance systems as per cGMP guidelines. To ensure that all manufacturing operations at the location comply with ICH Q7 system, documentation and records. To follow a system for releasing or rejecting all APIs. To follow up a system for releasing or rejecting intermediates for use outside the control of the manufacturing company. To follow a system to release or reject RM, Intermediates, packing and labeling materials. To perform product quality review. To prepare product labels and establish a system to control issuance of labels. To review raw data of analysis before release of the batch. To support Asst. Manager / Officer for Q.A activities like qualification, validation, calibration, and area monitoring. To prepare documents for customer questionnaires and support. To prepare, review and respond to the Regulatory Query. To fill the customer vendor questionnaire as per customer requirement & provide VQ related declaration. To prepare & review the DMF as per the pharmacopeia & customer requirement. To Submit the DMF to the Regulatory Authority as per the Regulatory requirement. To prepare & review declaration as per customer vendor questionnaire requirement. To perform Nitrosamine risk assessment as per the guideline requirement. To perform Genotoxic risk assessment as per the guideline requirement.

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp & Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp & Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp & Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Guide the upgrade and development of plant infrastructure and systems to meet the requirements of: WHO-GMP, Russia, Australia/New Zealand, and African regulatory authorities, Ultimately UKMHRA and USFDA. Provide expert support on: WHO-GMP and GLP.

Job Title: FDA & International Pharma Compliance Consultant (Excipients, API & Ingredients & Formulations) Location: Kutch, Gujarat (Remote advisory with periodic on-site presence) Experience: 2025 years in pharmaceutical manufacturing and regulatory compliance Salary: Competitive Education: Bachelors or Master’s in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline Kindly get in touch for career advancement opportunities with us at rupsha.saha@antal.com Roles & Responsibilities Guide the upgrade and development of plant infrastructure and systems to achieve compliance with: WHO-GMP Regulatory requirements of Russia, Australia/New Zealand, African authorities Ultimate readiness for UK MHRA and US FDA audits Provide expert support on: WHO-GMP and GLP compliance for excipients, APIs, and formulation ingredients Equipment qualification (DQ/IQ/OQ/PQ) and cleanroom classification Process and cleaning validation Quality Management Systems (QMS), documentation (SOPs, BMRs, BPRs) and change control protocols Advise on regulatory documentation strategy for DMF and CTD/ACTD filings, including supplier qualification Assist in product selection and formulation pipeline development, identifying high-potential excipients and formulations for domestic and export markets Train and mentor QA, QC, production, and R&D teams on global pharmaceutical standards and best practices Desired Profile 20–25 years’ experience in excipients, API or formulations manufacturing, with a top-tier pharmaceutical company Proven track record of preparing and leading facilities through US FDA, MHRA or TGA audits Deep working knowledge of: ICH Q7/Q8/Q9/Q10 WHO GMP and EU GMP Annexes Indian D&C Act & Schedule M Hands-on experience supporting DMF submissions and familiarity with USP, EP, BP and IP Prior consulting or leadership roles serving regulated export markets Strong grasp of product lifecycle management, export documentation and quality risk management for emerging markets Tech-savvy, with exposure to digital QMS or e-BMR systems (desirable) Awareness of sustainability and EHS standards for global audit readiness Excellent cross-functional collaboration skills spanning production, QA/QC, R&D and supply-chain teams About Antal Antal International is a 30-year-old global executive search and placement firm with a network of over 800 people across 35+ countries, originally based out of the UK.

Review the Lab validation Protocol and Report of CRD Review of Process Development report for DMF filing. Required Candidate profile Lead the DQA department to implement CGMP rules and regulations in Research & Development.

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Company: Job Overview: As a Project Manager, you will play a key role in coordinating with partners and stakeholders to ensure the successful delivery of critical business projects. Project Managers will navigate barriers and work closely with functional team members to guide each project to completion. This role requires cross-functional collaboration and impeccable organization skills to deliver projects in a timely manner and within budget. Minimum Qualifications: Bachelor's degree 5+ years of Project Management-relevant work experience in Finance 2+ years of managing operating budgets and/or project financials. 2+ years of work experience in a role requiring interaction with senior leadership (e.g., Director level and above). 2+ years of work experience in change management PMO, PMP, Agile Methodology or Six Sigma Project Management Certification. Principal Roles and responsibilities Gathers stakeholder needs and goals with guidance and executes communication plan for project team and stakeholders. Forms project team, and manages and prioritizes the work of the project team by establishing schedules and task assignments, and tracking tasks of team members. Creates project goals and prioritizes deliverables with guidance from project stakeholders. Create roadmap and plan for change management, assess change impact. Apply a structured methodology and lead change management activities, support communication efforts, Manages multiple projects of small to medium size or complexity and applies up-to-date project management knowledge to meet deadlines. Builds and execute project plans for small- to medium-sized projects which include schedule and resource forecasting, stakeholder identification, method and frequency of communication, scope, and prioritization. Identifies project issues and risks and creates a risk mitigation plan for small- to medium-sized projects. Manages project performance (e.g., on time, on budget, within scope, and with quality) for projects of small to medium size or complexity. Promotes project vision and objectives within project team and ensures project objectives are met. Supports the compliance of project plans by following best practices and procedures. Promotes collaboration with diverse project stakeholders. Level of Responsibility Taking responsibility for own work and making decisions with limited impact; impact of decisions is readily apparent Solid understanding of how people go through a change and the change process with knowledge of change management principles, methodologies and tools. Using verbal and written communication skills to convey basic, routine information about day-to-day activities to others who are fully knowledgeable in the subject area. Completing tasks that require multiple steps that must be performed in a specific order, using directions or manuals that accurately document the steps necessary to perform the tasks. Using deductive problem solving is required to solve moderately complex problems; most problems have defined processes of diagnosis/detection; some data analysis may be required. Exercising some creativity may be required to troubleshoot technical problems or deal with novel circumstances. Minimum Qualifications: Bachelor's degree. 4+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Experience Level- 5+ Years, Project/Change certified + successfully delivered Shift timing- EMEA shift (3 pm IST to 12 am IST), but should be flexible based on business needs Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact Qualcomm Careers.

Preparation of Technical documents like below: COA/ Certificate of Analysis Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement (CTMME) product team. Build technical solution per implementation project plan by working with various members of the product team and business partners. Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study Support requirements gathering and specification creation process for the development work. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle. Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges/bugs effectively . Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science Bachelor’s degree with 6 - 8 years of experience in Computer Science Diploma with 10 - 12 years of experience in Computer Science. Preferred Qualifications: Solid technical background, including understanding software development processes, databases, and cloud-based content systems. Experience with Python scripting, SQL queries, markup languages (XML, JSON) and familiarity with API-driven content delivery. Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements. Experience with product backlog management (e.g., Jira) and collaboration tools. Good-to-Have Skills: Experience with structured content management, content models, and modular content creation. Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.) Basic understanding of GenAI solutions. Good communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

,,, Position Summary: You will serve as a key technical liaison between customers and PrintForm's internal teams. This includes reviewing CAD models, offering DFM guidance, supporting quotation generation, and helping ensure successful part delivery, especially for CNC-machined and injection-molded components. Key Responsibilities: Design for Manufacturability (DFM) Analyse 3d CAD models and technical drawings to evaluate the manufacturability of parts. Provide DFM feedback for CNC Machining and Injection Molding processes, optimising for quality, cost, and lead time. Recommend design modifications to improve process efficiency and reduce manufacturing risk. Technical Quoting & Cost Estimation Assess part complexity, material requirements, tolerances, and finishes to support accurate quoting. Collaborate with the global supplier network to gather manufacturing feasibility data and cost inputs. Assist sales and project teams with technical insights for competitive quoting. CAD & Documentation Review Interpret engineering drawings and CAD data to validate technical accuracy. Ensure clear communication of technical requirements to suppliers and internal teams. Maintain documentation related to project specs, drawings, and customer interactions. Supplier Collaboration & Manufacturing Support Work closely with manufacturing partners to align expectations on process capability, tolerances, and delivery schedules. Troubleshoot production issues and support resolution by coordinating with suppliers and engineering teams. Drive quality assurance by validating that manufactured parts meet customer and PrintForm specifications. Customer Communication & Project Coordination Participate in customer calls to provide engineering guidance and clarify technical queries. Act as the technical liaison between customers, suppliers, and internal teams to ensure smooth project execution. Guide customers from prototype to production, focusing on manufacturability and scalability. Continuous Improvement & Knowledge Sharing Contribute to internal knowledge bases and best practice documents. Identify recurring technical challenges and suggest improvements to quoting, DFM, and production workflows. Stay updated on the latest CNC and injection molding technologies, tools, and materials. Cross-Functional Team Collaboration Collaborate with U.S.-based engineering, sales, and project management teams. Support the execution of multi-disciplinary projects across industries such as aerospace, medical, and consumer products. Maintain strong, proactive communication across global teams. Required Qualifications: Bachelor's degree in Mechanical or Manufacturing Engineering. Minimum of 4+ years of relevant experience in CNC Machining and Injection Molding. Proficiency in GD&T, machining fundamentals, mold design, and material properties (both plastics and metals). Skilled in CAD tools like SolidWorks, Fusion 360, or similar. Strong written and verbal communication skills in English. Proven ability to manage multiple projects and work in cross-functional, remote teams. Preferred Experience: Experience in customer-facing or applications engineering roles. Familiarity with cloud-based quoting or manufacturing platforms. Exposure to other manufacturing processes such as Die Casting and Sheet Metal Work Schedule: Night Shift (to align with U.S. time zones) Full remote flexibility within the defined shift hours Benefits: Performance-based incentives Remote work flexibility Health Insurance Opportunities for professional growth and global collaboration Why Join PrintForm? Be part of a fast-paced, innovation-driven global manufacturing company Work with U.S. and international customers and top-tier suppliers Gain exposure to diverse projects in aerospace, medical, energy, and more Contribute to a team where engineering talent is valued and supported

Manufacturing Engineering Design Manager Job Title: Manufacturing Engineering Manager Location: Mysore Karnataka Industry: Consumer Appliances / Food Tech Reporting To: Operations Head Job Summary The Manufacturing Engineering Design Manager will be responsible for overseeing the process development and manufacturing engineering of product at a contract manufacturer (CM). This role will ensure the successful transition of product design to scalable and cost-effective manufacturing, maintaining high quality and reliability standards. The candidate will collaborate with design, quality, and supply chain teams to establish robust production processes and drive continuous improvement. Key Responsibilities Manufacturing Process Development & Optimization Lead the development, validation, and optimization of manufacturing processes at contract manufacturers. Ensure Design for Manufacturability (DFM) & Design for Assembly (DFA) principles are integrated into product development. Develop and implement scalable automation and lean manufacturing solutions. Drive process standardization and ensure best practices across contract manufacturing sites. Supplier & Contract Manufacturer Management Select, evaluate, and onboard contract manufacturers based on technical capabilities, quality standards, and cost-effectiveness. Define manufacturing process requirements, line setup, and equipment specifications at CM facilities. Conduct process capability studies (Cpk, Ppk) and risk assessments (PFMEA, DFMEA). Establish and monitor key performance indicators (KPIs) for CM performance in yield, quality, and cost. Quality & Compliance Ensure compliance with regulatory and industry standards (ISO, FDA, CE, UL, etc.). Implement Statistical Process Control (SPC) and process validation (IQ, OQ, PQ). Develop corrective and preventive action plans (CAPA) for process deviations. Collaborate with the Quality team to establish robust inspection and testing protocols. New Product Introduction (NPI) & Engineering Change Management Lead the industrialization of new product variants and improvements at CM sites. Manage Engineering Change Orders (ECOs) and ensure smooth transitions in manufacturing. Support product cost-down initiatives through value engineering and material/process optimization. Cost & Efficiency Management Develop cost models for manufacturing processes and drive cost reduction initiatives. Optimize production efficiency, yield, and cycle time through Lean, Six Sigma, and Kaizen methodologies. Work closely with supply chain and procurement teams to ensure cost-effective sourcing. Cross-functional Collaboration Work closely with R&D, Product Design, Quality, and Supply Chain teams to ensure seamless integration between design and manufacturing. Provide technical support for troubleshooting manufacturing issues at CM facilities. Drive a culture of continuous improvement through problem-solving methodologies (8D, A3, Root Cause Analysis). Key Deliverables Successful Industrialization Develop and implement manufacturing processes ensuring smooth production ramp-up at CM. Process Qualification Establish and validate critical manufacturing processes to meet quality and cost targets. Supplier Performance Management Maintain CM performance metrics and drive improvements in yield, OEE, and cost. Cost Reduction & Efficiency Identify and implement cost-saving opportunities in manufacturing operations. Manufacturing Readiness Ensure production readiness for new product introductions and engineering changes. Regulatory Compliance Maintain adherence to industry and regulatory standards. Required Qualifications & Skills Bachelor's/Masters degree in Mechanical, Manufacturing, Industrial Engineering, or related field. 15+ years of experience in manufacturing engineering, process development, or industrialization. Strong expertise in consumer appliances, food tech, or electromechanical assembly. Hands-on experience in working with contract manufacturers, including supplier qualification and onboarding. Proficiency in Six Sigma, Lean Manufacturing, and process improvement methodologies. Knowledge of regulatory standards (ISO 9001, FDA, CE, UL) and compliance requirements. Experience with DFM, DFA, PFMEA, and SPC tools. Strong project management, analytical, and problem-solving skills. Excellent communication and stakeholder management abilities. Qualifications: Bachelors degree in Engineering or a related field; Masters degree preferred. Minimum of 10 years of experience in quality assurance/engineering, with at least 5 years in a managerial role. Strong understanding of Manufacturing Engineering methodologies, tools, and processes. Send updated CV- Mobile 91-9590270707 Email:- sp@intellisearchonline.net