Medical Device Labeling specialist

HCLTech is looking for a highly talented and self- motivated Medical Device Labeling specialist to join it in advancing the technological world through innovation and creativity. Job Title: Medical Device Labeling specialist Job ID: Position Type: Full-time with HCLTech Location: Milpitas, California, United States Role/Responsibilities Manage / lead / execute labeling project(s) involving NPD and current commercial products. Create / update the label artworks, label specifications, user manuals and its specifications and all other associated manufacturing instruction documents. Providing input to the offshore team to execute their tasks as per customer guidance / process / procedure. Create / update the design control documents, Bill of materials, drawings & other support documents and review of these documents from R&D’s technical specialty. Create / update the labeling design specification documents including artworks using graphic designing tools. Update the labels and user manuals as per EUMDR requirements Manage transactions in Product Lifecycle Management tool & review and update Bill of Materials. Create / Update Standard Operating Procedures & Manufacturing Work Instructions. Need to handle change control management activities in PLM tools. Accountable to initiate, plan and drive multiple projects throughout the project lifecycle. Follow-up with Work Stream Leads from Manufacturing Plants and cross functional teams to assimilate project information daily. Accountable to drive projects through planning, execution and close out phases. Accountable for project communication with teams, peers, and leadership. Manages project(s) risks and issues proactively. Knowledgeable with problem-solving skills, able to find innovative ways to resolve issues. Knowledgeable on EUMDR, 21CFR 820, ISO 13485, ISO 14971, ISO 15223, EN 1041 & ISO 20417.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/ or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor’s degree in mechanical engineering or equivalent; Master’s degree preferred. Minimum 5 years of industry experience with medical device labeling projects. Experience working in a highly regulated industry (e.g., medical device, pharmaceutical) including hands‑on experience in a medical device design control process. Knowledgeable of medical device quality systems, FDA, EUMDR and applicable ISO standards. Knowledge and hands‑on experience in EU MDR related projects are an advantage. Experience with problem solving methodologies. EDUCATION and/or EXPERIENCE Minimum undergraduate degree (BS) in Science, Mechanical/Industrial/Biomedical engineering 5 Years of medical/ pharmaceutical packaging design and development experience Pay and Benefits Pay Range Minimum: $45.00 per hour Pay Range Maximum: $54.00 per hour HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to View email address on click.appcast.io for investigation. Compensation and Benefits A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year. How You’ll Grow At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best. #J-18808-Ljbffr HCLTech