R&D Engineer
Johnson & Johnson AG | 4528 Zuchwil | Permanent | 100% Full-time
Responsibilities
Assists in the design and development of new implants and instrumentation and supports in-market products throughout their life cycle.
Collaborates 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.
Supports lead R&D engineers in developing conceptual models and drawing layouts, prototypes, verification and validation methods and reports, and required Design Control documentation.
Contributes 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.
Contributes to designs with consideration for manufacturing and inspection processes.
Contributes to mechanical test design, execution, and documentation.
Maintains basic knowledge of existing product lines and detailed knowledge of relevant anatomic injuries/pathologies and treatment options.
Supports assigned technical tasks as needed.
Understands and follows the New Product Development (NPD) process and maintains high-quality design verification and validation practices.
Supports clinician interactions to inform design development and to support clinical assessment of improvements and modifications.
Completes required documentation to support design and process changes and demonstrates proficiency in applying design controls and development processes.
Understands the IP process and supports initial patent reviews and freedom-to-operate assessments.
Supports operations projects, including cost improvement initiatives and production transfers.
Knows and follows all laws and policies applicable to the role and maintains the highest standards of professionalism, ethics, and compliance at all times.
Diligently participates in compliance program-related activities as directed by the supervisor or the Chief Compliance Officer.
Promotes and nurtures the highest standards of professionalism, ethics, and compliance and actively supports the Code of Business Conduct and compliance initiatives.
Supports quality and compliance activities, including audits, remediation projects, nonconformances, and regulatory compliance projects.
Participates in complaint and field investigation activities to support patient and customer safety.
Qualifications
Bachelor’s degree in Engineering or a related discipline is required; Mechanical Engineering is preferred.
Minimum 6 months of experience in the design and development of mechanical products is required.
Knowledge of biomechanics, biology, and anatomy is a plus.
Knowledge of medical device regulations, including GMP, QSR, ISO quality requirements, and GDP is preferred.
Knowledge of CAD software and manufacturing methods (especially machining), mechanisms, materials, tolerancing, drafting standards, and GD&T is preferred.
Experience designing medical devices and/or working in a machine shop environment is preferred.
Experience with plastic injection molding design and manufacturing is preferred.
Project management experience is preferred.
Demonstrated creative design ability.
Demonstrated ability to prioritize tasks and manage a varied workload.
Strong 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.
Good 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.
Proficiency utilizing the MS Office Suite is required.
Willing to work with wet tissues/cadaver and within an Operating Room setting is required.
German (business fluent) and English (business fluent) required.
#J-18808-Ljbffr