Position Summary
Lead the delivery of projects to maintain business continuity in areas such as complying with regulations, resolving product performance issues, sustaining supply chain continuity, and improving margins.
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, requirements definition, product development, root cause analysis, verification/validation and manufacturing aspects using Teleflex design control policies and procedures.
Aid in product improvement and cost reduction, facilitate change management and documentation, develop, troubleshoot and maintain manufacturing processes, equipment and systems. Work with component suppliers to develop new components and/or improve existing ones.
Perform product testing, create models and prototypes to prove out new designs and changes to existing designs.
Directly lead engineering efforts to develop components, specifications and processes with input from technical experts, physicians, marketing and manufacturing 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. Interface with suppliers, Strategic Sourcing, Quality and Regulatory Affairs to deliver projects.
Deliver or lead the resolution of manufacturing issues and conduct improvements of manufacturing processes through the use of statistical data analysis techniques such as Process Capability Studies, DOE and SPC. Provide uniform solutions for international manufacturing operations.
For both in house and purchased components, lead the transfer of parts, assemblies, documentation and processes from prototype stage, through pilot to production. Define specifications for the generation of products/processes including experimental activity specifications through production lifecycle for the Device Master Record as required.
Work related to compliance issues may include research of existing procedures and documentation as well as writing or revising standard operating procedures and other documentation.
Meet project objectives, milestones, and target dates. Update and review project progress on an as‑required basis by supervisor.
Interface with suppliers to obtain quotations, purchase components, and debug problems with production parts.
Direct and/or execute the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of products, processes, test fixtures, equipment, test procedures and documentation.
Lead and participate in design and technical phase reviews.
Support regulatory submissions and clinical trials as required.
Ensure projects are developed and documented compliant with the Quality System.
Adhere to and ensure the compliance of Teleflex's 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 considered.
2-3 years previous experience in a related field (e.g. medical device manufacturing and assembly, disposables manufacturing processes, plastics, automation) may be offset by advanced degrees.
Team player with good interpersonal skills.
Strong analytical, technical and problem‑solving skills.
Previous experience in design of medical devices preferred.
Hands‑on experience preferred.
Effective verbal and written communication skills.
Proficient in Microsoft Office Suite and SolidWorks or equivalent modelling system; familiar with statistical analysis (Minitab) and computerized analysis (FEA) applications.
Specialized Skills
Self‑motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals. Able to travel domestically and internationally.
Travel Required
Up to 10% of international travel, as required.
EEO Policy
Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.
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