Senior Engineer - Acute Disposables

Role & responsibilities

• Leads the evaluation and development of Disposables on assigned projects with focus on risk management. Owns and maintains the risk management files for the assigned product families.
• Manages all technical complexities of the work, and effectively communicates with all project team members and stakeholders. This includes reporting pertinent information at key milestones.
• Collaborates with cross functional team (e.g., Quality, regulatory, clinical) to ensure the proper deployment of risk management activities.
• Manages and prioritizes multiple projects and tasks.
• Develops solutions and approaches to complex problems through application and adaptation of state-of-the-art techniques.
• Able to clearly present moderately complex concepts and tailor communication to audiences, including senior management.
• Organizes and presents solutions from risk management perspective without assistance. Oral and written communication is well planned, organized and has a clear logical flow.
• Ensures successful integration of disposables design elements from risk management perspective into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the risk management tasks.
• Creates and maintains design documentation that includes requirements, specifications, verification reports, Bill of Materials, detailed engineering drawings, study reports and all documents that contribute to DHF of the product family.
• Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing ensuring acceptable risk profile of the device is maintained throughout the entire product lifecycle.
• Support, from risk management perspective, the necessary testing required to validate the safety and effectiveness of the design(s).

Preferred candidate profile

• Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or Equivalent
• Minimum of 6 years of relevant experience, Prior experience of technical leadership in Sustenance/New product development in Critical care Medical device domain is a plus.
• Experience in a regulated industry preferably medical devices and familiarity with ISO 13485, and ISO 14971

Qualifications

• Proficiency with MS Office and other office productivity tools.
• Self-directed, resourceful, and able to work on multiple projects and priorities.
• Strong organization, attention to detail, and documentation skills.
• Strong hands-on lab skills, and prototype fabrication skills.
• Very adept at grasping and solving complex problems using root-cause analysis techniques.
• Previous experience on product risk management is a plus.
• Ability to objectively identify technical solutions, and make sound engineering decisions.
• Clear and effective communication (written and oral) and presentation skills.
• A proven track record of effectiveness in a fast-paced environment.
• Proven ability to create results within budget, timeline, and product/project deliverables.