Ph3RD Engineer /h3 pJohnson Johnson AG | 4528 Zuchwil | Permanent | 100% Full-time /p h3Responsibilities /h3 ul liAssists in the design and development of new implants and instrumentation and supports in-market products throughout their life cycle. /li liCollaborates with design engineering, marketing, quality, supply chain, manufacturing, regulatory affairs, and Health Care Professionals to develop functional and design requirements and product concepts for new and existing products. /li liSupports lead RD engineers in developing conceptual models and drawing layouts, prototypes, verification and validation methods and reports, and required Design Control documentation. /li liContributes to documentation and Design Control activities to ensure compliance with MDR and FDA Design Control regulations and to support 510(k) submissions and/or IDE clinical studies. /li liContributes to designs with consideration for manufacturing and inspection processes. /li liContributes to mechanical test design, execution, and documentation. /li liMaintains basic knowledge of existing product lines and detailed knowledge of relevant anatomic injuries/pathologies and treatment options. /li liSupports assigned technical tasks as needed. /li liUnderstands and follows the New Product Development (NPD) process and maintains high-quality design verification and validation practices. /li liSupports clinician interactions to inform design development and to support clinical assessment of improvements and modifications. /li liCompletes required documentation to support design and process changes and demonstrates proficiency in applying design controls and development processes. /li liUnderstands the IP process and supports initial patent reviews and freedom-to-operate assessments. /li liSupports operations projects, including cost improvement initiatives and production transfers. /li liKnows and follows all laws and policies applicable to the role and maintains the highest standards of professionalism, ethics, and compliance at all times. /li liDiligently participates in compliance program-related activities as directed by the supervisor or the Chief Compliance Officer. /li liPromotes and nurtures the highest standards of professionalism, ethics, and compliance and actively supports the Code of Business Conduct and compliance initiatives. /li liSupports quality and compliance activities, including audits, remediation projects, nonconformances, and regulatory compliance projects. /li liParticipates in complaint and field investigation activities to support patient and customer safety. /li /ul h3Qualifications /h3 ul liBachelor’s degree in Engineering or a related discipline is required; Mechanical Engineering is preferred. /li liMinimum 6 months of experience in the design and development of mechanical products is required. /li liKnowledge of biomechanics, biology, and anatomy is a plus. /li liKnowledge of medical device regulations, including GMP, QSR, ISO quality requirements, and GDP is preferred. /li liKnowledge of CAD software and manufacturing methods (especially machining), mechanisms, materials, tolerancing, drafting standards, and GDT is preferred. /li liExperience designing medical devices and/or working in a machine shop environment is preferred. /li liExperience with plastic injection molding design and manufacturing is preferred. /li liProject management experience is preferred. /li liDemonstrated creative design ability. /li liDemonstrated ability to prioritize tasks and manage a varied workload. /li liStrong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is preferred. /li liGood communication skills; ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers, Health Care Professionals and/or teams across the organization. /li liProficiency utilizing the MS Office Suite is required. /li liWilling to work with wet tissues/cadaver and within an Operating Room setting is required. /li liGerman (business fluent) and English (business fluent) required. /li /ul /p #J-18808-Ljbffr