| 7 C2C requirements Manufacturing Eng R&D Engg Reliability Engg Design Quality Supplier Quality Supplier Quality at Remote, Remote, USA |
| Email: [email protected] |
| [email protected] Title : Mfg. Engineer (specialist) JD : Design, develop, and optimize manufacturing processes to improve efficiency and quality. Analyze production processes to identify areas for improvement and implement solutions. Develop and maintain process documentation, including standard operating procedures (SOPs) and work instructions. Collaborate with cross-functional teams, including production, quality, and maintenance, to ensure seamless operations. Conduct root cause analysis and implement corrective actions to resolve production issues. Monitor and analyze key performance indicators (KPIs) to drive process improvements. Able to conduct process audit in line with ISO standard Ensure compliance with safety, health, and environmental regulations. Lead continuous improvement projects using Lean, Six Sigma, and other methodologies. Train and mentor production staff on new processes and best practices. Manage and maintain equipment and tooling to ensure optimal performance. Key Skills and Qualifications: Bachelors degree in Manufacturing Engineering, Mechanical Engineering, or a related field. Proven experience as a Manufacturing Engineer or Process Engineer in a plant environment. Strong knowledge of manufacturing processes, production machinery, and automation techniques. Proficiency in CAD software and MS Office. Excellent analytical and problem-solving skills. Strong communication and interpersonal skills. Ability to work in a fast-paced environment and manage multiple projects. Knowledge of Lean, Six Sigma, and other continuous improvement methodologies Title : R&D Engg (specialist) JD: Design and develop test methods to support additional studies. Apply engineering principles to product design analysis and assessment. Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions. Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures. Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, etc. Coordinate and lead competitive testing and aging testing. Interact with physicians to assist with product demonstrations. Optimize and refine existing products. Develop familiarity with endovascular procedures and apply the knowledge to product development and product risk assessment. Provide guidance to technicians and pilot associates. Identify problems and recommend solutions. Qualification/YOE : Experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma). Good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements Masters degree in science, engineering, or a related field. PMP Certification preferred. Title : Reliability Engg (specialist) JD : Develop and implement reliability test plans and protocols. Conduct Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis. Perform statistical analysis and reliability data analysis. Collaborate with cross-functional teams to ensure design for reliability (DfR) principles are integrated into product development. Conduct accelerated life testing (ALT) and Weibull analysis. Ensure compliance with regulatory standards (FDA, ISO 13485). Develop and maintain reliability block diagrams (RBD) and reliability growth analysis. Support corrective and preventive actions (CAPA) to address reliability issues. Utilize reliability software tools (e.g., ReliaSoft, Minitab) for data analysis and reporting. Provide technical support and guidance to engineering teams on reliability-related matters Qualification/YOE : Bachelors degree in Engineering (Mechanical, Electrical, Biomedical, or related field). Minimum of [X] years of experience in reliability engineering, preferably in the medical device industry. Strong knowledge of reliability engineering principles and methodologies. Experience with reliability testing, statistical analysis, and risk management. Familiarity with regulatory requirements (FDA, ISO 13485). Proficiency in reliability software tools (e.g., ReliaSoft, Minitab). Excellent problem-solving skills and attention to detail. Strong communication and teamwork abilities. Title : Design Quality (specialist) JD : Represent Design Quality Engineering in medical device lifecycle management by engaging with cross-functional partners in system and product continuous improvement projects. Review modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Review risk management documents and conduct a change impact assessment with focus on product design for every change request that pertains to modifying released products. Perform statistical analysis of data generated including but not limited to: Process capability, Cpk, Ppk, Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria. Technical problem solving, compiles data and prepares reports on findings, to identify trends, proposes corrective action as needed. \\ Mentor junior quality engineers in providing quality engineering support for their medical device products Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards. Qualification: Experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma). Good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements Masters degree in science, engineering, or a related field. PMP Certification preferred. Title : Supplier Quality (specialist) JD : Lead the supplier qualification process by assessing manufacturing/technology capabilities. Conduct comprehensive gap assessments at target suppliers to identify areas for improvement and create individual supplier development plans. Work with suppliers and run SCN and PPAP activity Develop and refine comprehensive training materials to effectively deploy problem-solving, process control, and quality tools. Proactively identify and implement continuous improvement activities to prevent the recurrence of non-conformities, ensuring sustained process enhancements. Review supplier manufacturing processes and collaborate with suppliers on process improvement and value enhancement opportunities. Facilitate root cause analysis and corrective actions of supplier quality issues. Independently work with suppliers for the completion of PPAP, Special Process Validation IQ, OQ and PQ requirements. Knowledge of International standards relative to QMS, ISO 9001:2015, ISO 13485, and ASTM/ASME standards are preferred. Strong knowledge of Supplier Qualification, Supplier Production Part Approval Process (SPPA), conducting Product and Process Audit at the supplier end Tailor strategies based on supplier and activity feedback to ensure maximum deployment effectiveness. Collaborate with cross-functional teams to develop and enhance the overall supplier development process and phased rollout plans. Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers and deliver quality awareness training to suppliers. Monitor supplier progress and performance against pre-agreed objectives and goals, providing guidance and support as needed. Qualification: Bachelor's degree in engineering B. Tech / B.E preferred (E.g., Mechanical Engineering or equivalent) or a related field. 5-10 years of experience in Supplier Quality Engineering, preferably in the Medical Device Industry. Language Proficiency Strong ability in interpreting engineering drawings/prints. Proficiency in quality tools, risk analysis and statistical tools for problem-solving. Willingness and ability to undertake travel at the supplier end on a need basis. Exceptional verbal, written, presentation, and interpersonal skills. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint) Title : Project Management JD: Provide technical leadership and take ownership of critical technical tasks in the execution of new product development catheter projects. Liaise with key opinion leaders to develop a deep understanding of the disease state, gather user needs; and articulate throughout the team. Translate needs requirements into technical specifications. Foster a culture of creativity; generate creative product solutions to address unmet needs. Provide leadership to the team in the development of test models for prototype performance evaluations, building and testing of prototypes, test data analysis and interpretation, component and finished device assembly drawings/specifications, product materials selection, and process development. Hands-on approach where appropriate, leading critical activities by example. Identify and manage key technical risks and appropriate mitigations throughout the product lifecycle. Write and/or review procedures, protocols, specifications, and reports. Identify and recommend optimal solution(s) for commercialization. Interface with physicians; evaluate and assess user techniques and develop product training materials. Identify and support development of processes for new catheter developments. Support generation of Intellectual Property by filing new ideas and drafting patents as required. Encourage and support idea generation and filing across the engineering groups on site. Develop detailed technical project goals, plans and budget. Identify critical project tasks, define project strategy, and set team priorities. Identify and manage key program risks. Manage direct team and across functions to deliver on performance, time and cost targets. Report progress across the organisation. Leverage and liaise with external resources to achieve project goals. Manage project in accordance with quality system take ownership of design history file and lead design reviews. Develop marketing materials (presentations/videos/demos). Attend external meetings with key opinion leaders to present the client product portfolio and gain feedback on new product development. Perform other duties as assigned or required. Educational Background Bachelors Degree: Typically in project management, business administration, engineering, or a related field , Lifesciences. Masters Degree: Can be advantageous, especially for senior positions. Experience Project Management Experience: At least 3-5 years of experience in managing projects. Industry-Specific Experience: Relevant experience in the specific industry or field. Skills Communication: Excellent verbal and written communication skills. Leadership: Strong leadership and motivational skills. Organizational Skills: Ability to manage time and resources efficiently. Problem-Solving: Strong analytical and problem-solving abilities. Decision-Making: Effective decision-making skills. Technical Skills: Proficiency in project management software and tools, such as MS Project, JIRA, or Trello. Certifications Project Management Professional (PMP) Certified ScrumMaster (CSM) Certified Associate in Project Management (CAPM) Lean Six Sigma Certification Title : Regulatory (specialist) JD : Regulatory Submissions: Prepare and submit regulatory documents to agencies such as the FDA, EMA, and other global regulatory bodies. Regulatory Compliance: Ensure all products comply with relevant regulations, including FDA 21 CFR 820, ISO 13485, and CE marking requirements. Risk Management: Conduct risk assessments and develop mitigation strategies to ensure regulatory compliance. Quality Management System (QMS): Support the maintenance and improvement of the QMS to ensure ongoing compliance with regulatory standards. Clinical Trials: Oversee regulatory aspects of clinical trials, ensuring compliance with applicable regulations. Post-Market Surveillance: Monitor and report on the safety and effectiveness of medical devices after they are released to the market. Regulatory Strategy: Develop and implement regulatory strategies to support product development and market access. Document Control: Manage regulatory documents to ensure accuracy, completeness, and accessibility. Regulatory Inspections: Prepare for and manage regulatory inspections and audits. Global Regulatory Compliance: Ensure compliance with international regulations and standards. Education: Bachelors degree in Regulatory Affairs, Life Sciences, Engineering, or a related field. Experience: Minimum of 3-5 years of experience in regulatory affairs within the medical device industry. Knowledge: Strong understanding of FDA 21 CFR 820, ISO 13485, CE marking, and global regulatory requirements. Skills: Excellent problem-solving, communication, and project management skills. Certifications: Relevant certifications (e.g., Regulatory Affairs Certification (RAC)) are a plus. -- Keywords: artificial intelligence rlang information technology container edition microsoft 7 C2C requirements Manufacturing Eng R&D Engg Reliability Engg Design Quality Supplier Quality Supplier Quality [email protected] |
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| Wed Oct 30 20:19:00 UTC 2024 |