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.