R&D Engineer Tracheostomy

Position Summary

Lead the delivery of projects to maintain business continuity in areas such as new product introduction and sustaining engineering of existing products in the Tracheostomy portfolio.

Principal Responsibilities

•    Work related to products and components may include efforts in all technical phases of product and process development, including design and development planning and execution, requirements definition, root cause analysis, verification/validation and manufacturing aspects using companies design control policies, as well internal business processes. 
•    Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
•    Lead engineering efforts to develop components, specifications and processes with input from technical experts, clinicians, marketing and manufacturing while adhering to the design control process. 
•    Lead projects in the redesign or replacement of existing components/assemblies and processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner. 
•    Perform product testing, create models and prototypes to prove out new designs and changes to existing designs.
•    Coordinate both virtual and in-person interactions with manufacturing sites, suppliers, and cross-functional teams (Engineering, Sourcing, Quality, and Regulatory Affairs) to deliver projects.
•    Participate in Front End Innovation (FEI) activities for the New Product Development pipeline, including market research, concept generation and development.
•    Interface with suppliers to obtain quotations, purchase components, and debug problems with production parts.
•    Lead and participate in design and technical phase reviews.
•    Support regulatory submissions, CAPAs, NCs  and clinical trials as required.
•    Adhere to and ensure the compliance of Companies Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

•    Bachelor of Science in Mechanical or Biomedical Engineering preferred; other technical disciplines will be considered.
•    1-3 years previous experience in related field (e.g. medical device manufacturing and assembly, disposables manufacturing processes, plastics, automation.
•    Strong analytical, technical and problem-solving skills.
•    SolidWorks or equivalent modelling system proficiency and technical documentation essential.
•    Previous experience in design of medical devices preferred.
•    Effective verbal and written communication skills.
•    Team player with good interpersonal skills.
•    Proficient in Microsoft Office Suite; familiar with statistical analysis (Minitab) applications.

Specialized Skills / Other Requirements

•    Self-motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals.
•    The ideal candidate will display excellent multi-tasking, analytical, communication and prioritisation skills. 

TRAVEL REQUIRED: <10 %.

WORKING ENVIRONMENT: Office/Professional (Hybrid)

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