01.15.15
The Project Engineer, Product and Process Support will individually lead the delivery of projects to maintain business continuity in areas such as 1) complying with regulations; 2) resolving product performance issues; 3) sustaining supply chain continuity; and 4) improving margins.
Teleflex® offers a broad range of central venous access catheters through its proven and trusted ARROW® technologies designed to minimize risk and maximize outcomes. Our new VasoNova™ central venous catheter navigation technology is designed to enable the optimal position for catheter tip location. Visit www.teleflex.com to view our vascular products and learn more about educational opportunities to learn more about vessel health and preservation.
KEY RESPONSIBILITIES:
Individually lead the delivery of projects to maintain business continuity in areas such as 1) complying with regulations; 2) resolving product performance issues; 3) sustaining supply chain continuity; and 4) improving margins.
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 Arrow's design control policy 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.
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.
•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, R&D, Quality and Regulatory Affairs to deliver projects.
•For in house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement and existing products and components.
•Individually deliver or guide technical resources in the development/improvement of products and processes, optimize them utilizing tools such as DOE, accomplish their evaluation through verification and validation, and assist in their implementation with appropriate controls and metrics.
•For in house components, train manufacturing management, operator and set-up personnel to manufacture according to specifications.
•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.
•Manage supplier initiated changes as required to sustain supply chain following applicable standard operation procedures.
•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.
•Interface with purchasing and marketing to develop supplier agreements for components and/or new products.
•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.
•As requested, work with the Product Performance Team and R&D personnel to lead investigation of product complaints to determine root cause and implement corrective action.
•Mentor others in learning the requirements of and operate in a medical device manufacturing environment.
•Mentor others in learning the best practices and develop skills in project management and technical writing.
•Direct 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.
•Interview, recommend and assist in selection of department personnel including engineers and summer interns.
•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.
BASIC QUALIFICATIONS:
•Bachelor of Science or Professional Engineer Certification – Engineering or technical discipline
•5+ years of experience with PC boards, components and cables.
•Medical device development and manufacturing experience desired.
•Strong analytical and problem-solving skills.
•Effective verbal and written communication skills.
•Team player with good interpersonal skills.
•Proficient in Microsoft Office Suite and computerized analysis applications.
•Self-motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals.
•Able to travel domestically and internationally.
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.
Teleflex® offers a broad range of central venous access catheters through its proven and trusted ARROW® technologies designed to minimize risk and maximize outcomes. Our new VasoNova™ central venous catheter navigation technology is designed to enable the optimal position for catheter tip location. Visit www.teleflex.com to view our vascular products and learn more about educational opportunities to learn more about vessel health and preservation.
KEY RESPONSIBILITIES:
Individually lead the delivery of projects to maintain business continuity in areas such as 1) complying with regulations; 2) resolving product performance issues; 3) sustaining supply chain continuity; and 4) improving margins.
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 Arrow's design control policy 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.
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.
•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, R&D, Quality and Regulatory Affairs to deliver projects.
•For in house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement and existing products and components.
•Individually deliver or guide technical resources in the development/improvement of products and processes, optimize them utilizing tools such as DOE, accomplish their evaluation through verification and validation, and assist in their implementation with appropriate controls and metrics.
•For in house components, train manufacturing management, operator and set-up personnel to manufacture according to specifications.
•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.
•Manage supplier initiated changes as required to sustain supply chain following applicable standard operation procedures.
•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.
•Interface with purchasing and marketing to develop supplier agreements for components and/or new products.
•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.
•As requested, work with the Product Performance Team and R&D personnel to lead investigation of product complaints to determine root cause and implement corrective action.
•Mentor others in learning the requirements of and operate in a medical device manufacturing environment.
•Mentor others in learning the best practices and develop skills in project management and technical writing.
•Direct 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.
•Interview, recommend and assist in selection of department personnel including engineers and summer interns.
•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.
BASIC QUALIFICATIONS:
•Bachelor of Science or Professional Engineer Certification – Engineering or technical discipline
•5+ years of experience with PC boards, components and cables.
•Medical device development and manufacturing experience desired.
•Strong analytical and problem-solving skills.
•Effective verbal and written communication skills.
•Team player with good interpersonal skills.
•Proficient in Microsoft Office Suite and computerized analysis applications.
•Self-motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals.
•Able to travel domestically and internationally.
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.
