Lead Hardware Engineer
Your Responsibilities will include :
Leading the complete activity end to end on Value Engineering activities and ensuring its handled in an efficient and effective way
Being an active participant of team and look for optimizing Hardware design and improvement opportunities.
Generate Ideas for enhancing the quality & reliability of the product, cost savings etc.,
Spearhead and drive the design changes from start to end which may include Conceptualization, building prototypes with vendors, testing, conducting TDR (technical design reviews), taking it through design change process and implementation.
Support in analyzing customer complaints, manufacturing / supplier related issues and getting into the root cause analysis and taking corrective actions from the Hardware perspective
You will be forward looking for foresee the risks coming up internally or externally and prepare plans to address the same.
Working with the Global teams and ensuring the idea behind the concepts of design changes or Hardware strategy is being properly communicated and being addressed efficiently
Perform Hardware testing both in external and internal labs. Finalizing the reports and ensuring the tests are in compliance with the standards.
Being aware of and compliant with the Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Identify and report any quality or compliance concerns and take immediate corrective action as required
Drive compliance/closure of Regulatory and Quality requirements before approving Design Control and New New Product Introduction (NPI) program milestones
Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
Develop an open quality culture within the organization that fosters issue discussion and decision-making based on quality and compliance objectives
Bachelors degree in in Electronics /Biomedical Engineering
6+ years Industry experience as an engineer within the appropriate field of study.
4 + years’ experience in working in a MNC with teams located in different locations.
Experience in design and development of medical systems/ devices.
Excellent communication and presentation skills, with the ability to work harmoniously within a team
Analytic, creative, and business focused problem solver
Good understanding of Digital circuits fundamentals, expertise in circuit design methodology for high speed and low power circuit design.
Relevant experience in Analog and Mixed Signal Circuit Design of complex, high density, miniature PCB assemblies.
Demonstrated experience with New Product Introduction (NPI) regulatory compliance process, design history file and related documentation
Familiarity with ISO, FDA and other regulatory standards like IEC 60601, CISPER 11 etc.
Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
Demonstrated skills in proactively identifying, facilitating, and driving completion of a product/program
Strong interpersonal skills and ability to successfully work within and influence cross functional team members
Demonstrated ability to deliver results in an ambiguous environment.
Experience in utilizing lean and six-sigma methodologies.