Technical Manager

Location: Santa Clara, CA and various unanticipated locations throughout the U.S. Job Title: Technical Manager (HCLA50) Multiple positions available Job Description: Manage a team of about 15-20 members. Monitor timely completion of clinical evaluation and post-market surveillance (PMS) deliverables of high-risk medical devices for client. Review medical devices specific documents such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), periodic literature screening report, PMS plan, post-market clinical follow-up (PMCF) plan, PMCF report and PMS report. Train and mentor the team on process and regulatory requirements. Prepare document specific templates based on the Medical Device Regulations and Medical Device Coordination Group documents requirements. Ensure high quality deliverables and monitor the progress of the program with metrics. Provide End to End project delivery with focus on Quality, on time delivery and within the budget. As an initial note, no international travel will be required for this position. This position will require travel within the U.S. Travel and work at client sites as assigned. Job Requirements: Requires Masters degree or foreign equivalent in Pharmaceutical Science, Computer Science, Engineering (Any), Information Technology, Computer Technology, Computer Information Systems, Management Information Systems or related field plus one (1) year of experience in the job offered, or related IT or engineering role. Will accept a Bachelors degree plus five (5) years of described experience in lieu of Masters degree plus one (1) year of described experience. Any suitable combination of education, training, or experience is acceptable. Base Salary: $229,258 - $230,000/Year (whatever range we reasonably expect to hire a candidate within based upon our internal salary grid). Exact compensation may vary based on skills, experience, education, and/or to comply with federal or state law. As an initial note, no international travel will be required for this position. This position will require travel within the U.S. Travel and work at client sites as assigned. How to apply: Email resume, referencing HCLA50, including job history, to: HCL America, Inc.is an Equal Opportunity Employer.