Teleflex
Sustaining Engineer III
This role for Teleflex Interventional Urology Unit is based in Pleasanton, CA. As part of the Interventional Business Unit's Research & Development Team, the Sustaining Engineer III role provides engineering support to design and/or process alterations to existing products. Principal responsibilities include: Coordinate Design Change and Process Change activities for the impact to the organization; create evidence-based project proposals in alignment with quality system requirements Support engineering activity required to support products through the commercialized life cycle Develop design inputs and design outputs for changes to existing product or newly distributed product Ensure high-quality R&D functional deliverables, including detailed review of design, risk, and other relevant Design Phase deliverables to ensure accuracy of content and compliance with Design Control Procedures Support process validation for processes and products including IQ, OQ, PQ & PPQ Develop new test methods and/or alter existing test methods Provide R&D support for verification, qualification, and validation studies on existing products Support risk management activities and risk management reviews on existing products Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA's, and report generation Support regulatory approvals and responses to regulatory questions for existing products Maintain and supplement design history files that are thorough and accurate for existing product Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary Education/experience requirements include: Bachelor's degree (in Mechanical Engineering, Biomedical Engineering or related major) Minimum 5 years related experience working in a new product development, sustaining engineering in medical device industry or at least 3 years of medical device experience with Master's; or a PhD without experience. Specialized skills/other requirements include: Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, stamping, adhesive and thermal bonding and various other processes for medical device fabrication and design is preferred Self-motivated individual with proven ability to work independently from objectives Proven problem solving and trouble shooting skills Experience with quality management systems and medical device regulations Proven communication skills with cross-functional interaction Experience with ISO13485, MDD, FDA Quality System Regulations The pay range for this position at commencement of employment is expected to be between $120,000 - $125,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental, and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered.
This role for Teleflex Interventional Urology Unit is based in Pleasanton, CA. As part of the Interventional Business Unit's Research & Development Team, the Sustaining Engineer III role provides engineering support to design and/or process alterations to existing products. Principal responsibilities include: Coordinate Design Change and Process Change activities for the impact to the organization; create evidence-based project proposals in alignment with quality system requirements Support engineering activity required to support products through the commercialized life cycle Develop design inputs and design outputs for changes to existing product or newly distributed product Ensure high-quality R&D functional deliverables, including detailed review of design, risk, and other relevant Design Phase deliverables to ensure accuracy of content and compliance with Design Control Procedures Support process validation for processes and products including IQ, OQ, PQ & PPQ Develop new test methods and/or alter existing test methods Provide R&D support for verification, qualification, and validation studies on existing products Support risk management activities and risk management reviews on existing products Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA's, and report generation Support regulatory approvals and responses to regulatory questions for existing products Maintain and supplement design history files that are thorough and accurate for existing product Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary Education/experience requirements include: Bachelor's degree (in Mechanical Engineering, Biomedical Engineering or related major) Minimum 5 years related experience working in a new product development, sustaining engineering in medical device industry or at least 3 years of medical device experience with Master's; or a PhD without experience. Specialized skills/other requirements include: Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, stamping, adhesive and thermal bonding and various other processes for medical device fabrication and design is preferred Self-motivated individual with proven ability to work independently from objectives Proven problem solving and trouble shooting skills Experience with quality management systems and medical device regulations Proven communication skills with cross-functional interaction Experience with ISO13485, MDD, FDA Quality System Regulations The pay range for this position at commencement of employment is expected to be between $120,000 - $125,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental, and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered.