Engineering Manager

1 month ago

Hyderabad, India AMS Full time

We are hiring for a MedTech organization which is a prominent player in the medical device industry, recognized for its commitment to advancing healthcare through cutting-edge technologies and therapies. With operational and executive headquarters based in U.S.A. and having global presence in more than 150 countries, making a positive impact on the lives of individuals worldwide.


Engineering Manager - Medical Device Regulation


Job Responsibilities:


  • Oversee the company's drug or medical devices surveillance program, managing intake, protocol development, evaluation, processing, and follow-up on adverse reports.
  • Ensure accurate maintenance and reporting of Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) data as mandated by regulatory agencies.
  • Review and analyze clinical databases to extract ADE data and integrate it into a unified database, ensuring accuracy and quality of safety summaries.
  • Act as a liaison internally and externally to develop programs and processes meeting regulatory reporting requirements.
  • Provide leadership to a team handling complaints, evaluating strategies for operational transformation and continuous improvement.
  • Evaluate incoming complaint information, maintain electronic records, and conduct follow-up activities to gather additional data.
  • Determine reportability of complaints to government agencies and categorize them appropriately to ensure trend accuracy.
  • Collaborate with various departments within the company and external entities such as customers, vendors, and healthcare professionals.


Minimum Qualifications:


  • Bachelor's degree in Engineering or Science (e.g., SW, EE, ME, Biomedical Engineering) preferred.
  • 20+ years of quality assurance or regulatory experience in the medical or pharmaceutical industry.
  • Proficiency in Word, Excel, Access, PowerPoint, and database trending analysis.
  • Strong typing skills and ability to write business documents with minimal supervision.
  • Excellent verbal and written communication skills with a team-oriented approach.
  • Proactive leadership ability to lead technical initiatives.
  • Strong multitasking skills.
  • Understanding of complex medical device functionality and intended use.
  • Occasional travel may be required.


Differentiating Factors:


  • Autonomy: Manage subordinate supervisors and/or experienced professionals with latitude and independence in assignments.
  • Provide tactical and/or operational leadership and coaching.
  • Establish operational plans and implement policies and strategies impacting program schedules and customer satisfaction.
  • Propose modifications to functional operating policies and processes to drive continuous improvement.
  • Handle complex and undefined problems requiring detailed analysis and investigation.
  • Communicate effectively with internal and external stakeholders, influencing cooperation without direct command.
  • Manage a team of supervisors and/or experienced professionals, authorizing hiring, firing, promotion, and rewards within the area.
  • Knowledge of medical device development and quality control.
  • Familiarity with FDA, MEDDEV, and Canadian Regulations.

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