Technical Lead

GENERAL FUNCTION

Onsite Lead plans, leads, reviews and front-ends Design Verification, Sustaining Engineering and New Product Development projects as a technical contributor cum project leader and engages in all aspects of product development.

EDUCATION

• Bachelor’s or higher education in Mechanical Engineering or related engineering/technology streams (Manufacturing / Mechatronics / Polymer Science / BioMedical)

EXPERIENCE

• At least 5-7 years of working experience in design and development of Medical products, preferably in a regulated industry Medical Device.

CORE SKILLS

• MUST have excellent communication skills(verbal, written, presentation & articulation), appropriate for varying levels of stakeholders.
• Strong project management background in R&D or manufacturing environment
• Strong experience in tolerance analysis of plastic components in molding and assembly.
• Excellent analytical and problem-solving skills, as well as a good background in product development/manufacturing process specifically in high volume molding & assembly operations.
• Experience in leading and managing a small group of engineers and technicians
• Demonstrated ability to effectively, critical thinking and clearly communicate concepts, ideas, and knowledge to other individuals and teams.
• Experience in fixture design & development and test method development, implementation and validation.
• Desirable experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes.
• Good on statistical concepts such as in measurement system analysis and design verification.
• Proficient in Microsoft Office products with an emphasis on MS projects, Excel and Word.

RESPONSIBILITIES

• Leads the Design Verification, Sustaining Engineering & New Product Development projects and applies the best engineering practices and tools.
• Demonstrates excellent project management, contributes on projects as the R&D member, carrying out assigned responsibilities in a timely, diligent, safe and professional manner.
• Develops and maintains good rapport with business leaders, other internal functions, technical consultants, outside vendors, and other stakeholders to accomplish project objectives and be a strong team-player.
• Reviews the deliverables to ensure completeness, accuracy, and appropriateness of the design output/test executed and ensure its compliance with Good Documentation Practices.
• Provides training to the team on GDP/GLP, IQ/OQ process, Calibration & Preventive maintenance activities and ensures the quality of deliverables.
• Involves in the review/creation of DV Protocols and provides valuable inputs regarding test equipment selection, capability/accuracy, sample size optimization, acceptance criteria definition, etc.
• Conducts Weekly Status Review Meeting with stakeholders, shares the progress of various projects supported/led, keeps a track on the self-utilization.
• Promptly follow-up with the parties concerned for review/approval/signatures of project artifacts (including Memos, MSA, DV Protocol & Reports, IQ/OQ Protocols & Reports, etc).
• Quality System accountability: Maintains all relevant Protocols, Procedures, Reports and Records to ensure strict compliance of R&D functional operation to meet the Quality System requirements.
• Supports the organization’s intellectual property strategy by documenting data and independent, unique and patentable ideas that result from experimentations.
• Performs any other tasks (like Sustaining Engineering / New Product Development activities), as assigned.
• Bachelor’s or higher education in Mechanical Engineering or related engineering/technology streams (Manufacturing / Mechatronics / Polymer Science / BioMedical)

Thanks & Regards, Akriti Gupta Talent Acquisition Group HCL America Inc. 11000 Regency Parkway, Suite # 10, Cary, NC – 27518. Desk +1 (714) 599 9225, Ext. 6014143