R&D Engineer

Position Overview

Position: R&D Engineer – Biomedical Engineering (Orthopedics)

Location:

Zuchwil, Switzerland

Job Function: R&D Product Development;
Sub Function:
Biomedical Engineering;
Category:
Scientific/Technology

We develop the next generation of smarter, less invasive, more personalized orthopedics solutions as part of Johnson & Johnson’s Orthopedics teams, which support more than 6million people in any year. You will collaborate with cross‑functional teams to design, develop, validate, and refine implant and instrumentation products throughout their lifecycle.

After the planned separation, the successful candidate will become an employee of De Puy Synthes , and employment will be governed by De Puy Synthes  policies, benefits, and processes.

• Assist in the design and development of new implants and instrumentation and support in‑market products throughout their life cycle.
• Collaborate 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.
• Support lead R&D engineers in developing conceptual models, drawing layouts, prototypes, verification and validation methods and reports, and necessary Design Control documentation.
• Contribute to documentation and Design Control activities to ensure compliance with MDR and FDA Design Control regulations and support 510(k) submissions and/or IDE clinical studies.
• Contribute designs with consideration for manufacturing and inspection processes.
• Contribute to mechanical test design, execution, and documentation.
• Maintain basic knowledge of existing product lines and detailed knowledge of relevant anatomic injuries/pathologies and treatment options.
• Support assigned technical tasks as needed.
• Understand and follow the New Product Development (NPD) process and maintain high‑quality design verification and validation practices.
• Support clinician interactions to inform design development and to support clinical assessment of improvements and modifications.
• Complete required documentation to support design and process changes and demonstrate proficiency in applying design controls and development processes.
• Understand the IP process and support initial patent reviews and freedom‑to‑operate (FTO) assessments.
• Support operations projects, including cost‑improvement initiatives and production transfers.
• Know and follow all laws and policies applicable to the role and maintain the highest standards of professionalism, ethics, and compliance.
• Diligently participate in compliance program‑related activities as directed by the supervisor or Chief Compliance Officer.
• Promote and nurture the highest standards of professionalism, ethics, and compliance and support the Code of Business Conduct and compliance initiatives.
• Support quality and compliance activities, including audits, remediation projects, nonconformances, and regulatory compliance projects.
• Participate in complaint and field investigation activities to support patient and customer safety.

• Bachelor’s degree in Engineering or a related discipline (Mechanical Engineering preferred).
• Minimum 6 months of experience in the design and development of mechanical products (e.g., through a college co‑op, internship, or research).
• Knowledge of biomechanics, biology, and anatomy is a plus.
• Knowledge of medical device regulations, including GMP, QSR, and ISO quality requirements (preferred).
• Knowledge of GDP is preferred.
• Knowledge of CAD software is preferred.
• Knowledge of manufacturing methods (especially machining), mechanisms, materials, tolerancing, drafting standards, and geometric dimensioning and tolerancing (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 (e.g., through a college co‑op, internship, or research) is preferred.
• Demonstrated creative design ability.
• Demonstrated ability to prioritize tasks and manage a varied workload.
• 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 (preferred).
• Good communication skills – 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 (required).
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) (required).
• Willingness to work with wet tissues/cadaver and within an Operating Room setting (required).
• German:
  Business fluent;
  English:
  Business fluent.