Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

(Associate) R&D Engineer– Johnson & Johnson MedTech, Zuchwil

Objectives of the Position

• Assist in the design and development of new implants and instrumentation and/or support in-market products through their product life-cycle.
• Works with design engineers, marketing, quality, supply chain, manufacturing, regulatory affairs, Health Care Professionals and other team members to develop functional and design requirements and concepts on new and/or existing products.
• Supports lead R&D Engineers to develop: conceptual models and drawing layouts; prototypes; verification and validation methods and reports; and required Design Control documentation.
• Contributes to the required activities for documents to ensure compliance with MDR; FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies.
• Contributes to the development of design inclusive of manufacturing processes, and inspection processes.
• Contributes to mechanical test design and execution.
• Basic knowledge of existing product lines and detailed knowledge of applicable anatomic injuries/pathologies as well as treatment options
• Support technical tasks.
• Understands and follows the New Product Development process accurately and maintains high quality design validation and verification.
• Supports clinician-interactions for purpose of design development, and clinical assessment of improvements and modifications.
• Completes necessary documentation to support design/process changes; demonstrated proficiency in the application of design controls and development processes.
• Understands the IP process and supports initial patent review of designs for freedom to operate.
• Support operations projects associated with cost improvement projects and production transfers.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participates in compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Promotes and nurtures the highest standards of professionalism, ethics and compliance, and actively support our code of business conduct, compliance program-related initiatives and activities.
• Support quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.
• Participate in complaint investigations and field investigation activities in support of patient/customer safety.

EXPERIENCE AND EDUCATION

• A minimum of a bachelor’s degree in engineering or related discipline is required; Mechanical Engineering degree is preferred.
• Previous experience (0-2 years maximum) in the design and development of mechanical products, gained through college co-op, internship or research.

• German: Business fluent is required
• English: Business fluent is required
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required.
• Knowledge of bio mechanics, biology, anatomy is a plus.
• Knowledge of the medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements is preferred.
• Knowledge of GDP (Good Documentation Practice) is preferred.
• Knowledge of CAD software is preferred.
• Knowledge of various types of manufacturing (especially machining), mechanisms, materials, proper tolerancing, drafting standards, and an understanding of geometric dimensioning and tolerancing (GD&T) is preferred.

• Experience with designing medical device or working in a machine shop environment is preferred.
• Experience in plastic injection molding product design and manufacturing is preferred.
• Prior project management experience, gained through college co-op, internship or research is preferred.
• Demonstrated creative design ability.

• Demonstrated ability to prioritize tasks and manage a varied workload.

What you will need to Succed

• Demonstrates 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 - The ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers, e.g. Health Care Professionals and/ or teams across the organization is required.

• Willing to work with wet tissues/cadaver and within an Operating Room setting is required.