Technical Lead
Apply NowCompany: Futran Tech Solutions Pvt. Ltd.
Location: Skaneateles Falls, NY 13153
Description:
Job Description & Skill Requirement:
Project management
Work closely with operations and the business functions to ensure quality, performance of products and processes for medical devices Remediation lifecycle.
Responsibilities:
Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies.
Perform gap assessment and conduct remediation of documents with stakeholder inputs.
Experienced in FDA 510 K submissions, Nonconformance audits, EU MDR remediation processes.
Good understanding on the manufacturing specific QMS documents for Class-I, II and III medical devices.
Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA.
Creation/modification of process flows within the Manufacturing/Service Departments.
Development and maintenance Manufacturing/Service Work Instructions and related documents.
Creation/modification of fixtures, tooling, equipment and systems to support operations.
IQ, OQ, and PQ of fixtures, tooling, and equipment.
Monitor and drive corrective action, CAPA and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred.
Must be able to work well as a member of a team with the ability to adapt quickly to changes and work efficiently in a fast-paced environment.
Qualification:
Bachelor's degree in biomedical engineering/ mechanical engineering/industrial engineering background
"LTTS is an Equal Opportunity Employer and maintains a clear policy against discrimination based on age, disability, sex, race, religion or belief, gender reassignment, marriage/civil partnership, pregnancy/maternity, or sexual orientation. As an inclusive organization, we actively endorse equal opportunities for all candidates with the right mix of talent, skills, and potential. We encourage applications from a diverse pool of candidates and selection for roles will solely be based on individual merit."
"L&T Technology Services LTD is an equal opportunity employer and is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require any accommodations to participate in the recruitment process or to perform the essential functions of the job, please let us know. We will work with you to provide reasonable accommodations in accordance with applicable law."
External Skills And Expertise
"Bachelor's degree in science, engineering, or manufacturing discipline
Previous experience in engineering or project management is typically required.
Experience in ISO-13485 certified and cGMP organizations preferred. Medical DHF/DMR Remediation, QMS documenation, Gap Assessment
10-12 Years experience to lead and drive projects.
Process and Equipment Validation experience is optional but added benefit"
Project management
Work closely with operations and the business functions to ensure quality, performance of products and processes for medical devices Remediation lifecycle.
Responsibilities:
Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies.
Perform gap assessment and conduct remediation of documents with stakeholder inputs.
Experienced in FDA 510 K submissions, Nonconformance audits, EU MDR remediation processes.
Good understanding on the manufacturing specific QMS documents for Class-I, II and III medical devices.
Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA.
Creation/modification of process flows within the Manufacturing/Service Departments.
Development and maintenance Manufacturing/Service Work Instructions and related documents.
Creation/modification of fixtures, tooling, equipment and systems to support operations.
IQ, OQ, and PQ of fixtures, tooling, and equipment.
Monitor and drive corrective action, CAPA and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred.
Must be able to work well as a member of a team with the ability to adapt quickly to changes and work efficiently in a fast-paced environment.
Qualification:
Bachelor's degree in biomedical engineering/ mechanical engineering/industrial engineering background
"LTTS is an Equal Opportunity Employer and maintains a clear policy against discrimination based on age, disability, sex, race, religion or belief, gender reassignment, marriage/civil partnership, pregnancy/maternity, or sexual orientation. As an inclusive organization, we actively endorse equal opportunities for all candidates with the right mix of talent, skills, and potential. We encourage applications from a diverse pool of candidates and selection for roles will solely be based on individual merit."
"L&T Technology Services LTD is an equal opportunity employer and is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require any accommodations to participate in the recruitment process or to perform the essential functions of the job, please let us know. We will work with you to provide reasonable accommodations in accordance with applicable law."
External Skills And Expertise
"Bachelor's degree in science, engineering, or manufacturing discipline
Previous experience in engineering or project management is typically required.
Experience in ISO-13485 certified and cGMP organizations preferred. Medical DHF/DMR Remediation, QMS documenation, Gap Assessment
10-12 Years experience to lead and drive projects.
Process and Equipment Validation experience is optional but added benefit"