R&D Engineer

Role Overview

In this dynamic position, you will play a vital role in the design and development of innovative implants and instruments while supporting in-market products throughout their entire life cycle.

Key Responsibilities

• Assist in designing and developing new implants and instrumentation.
• Collaborate with cross-functional teams including design engineering, marketing, quality, supply chain, manufacturing, regulatory affairs, and Health Care Professionals (HCPs) to establish functional and design requirements.
• Support lead R&D engineers in creating conceptual models, drawing layouts, prototypes, and verification and validation methods.
• Contribute to documentation and Design Control activities to ensure compliance with MDR and FDA regulations and support for 510(k) submissions and/or IDE clinical studies.
• Incorporate manufacturing and inspection considerations into the design process.
• Assist in the mechanical testing design, execution, and documentation.
• Maintain knowledge of existing product lines and relevant anatomical injuries/pathologies.
• Support assigned technical tasks and follow the New Product Development (NPD) process.
• Engage with clinicians to inform design development and assess clinical improvements.
• Complete necessary documentation for design and process changes, demonstrating proficiency in design controls.
• Understand the intellectual property (IP) process and assist with initial patent reviews and freedom-to-operate (FTO) assessments.
• Support operations projects including cost improvement initiatives and production transfers.
• Uphold professionalism, ethics, and compliance with laws and policies relevant to the role.
• Participate actively in compliance program activities as directed by the supervisor or Chief Compliance Officer.
• Promote high standards of ethics and support compliance initiatives.
• Engage in quality and compliance activities including audits and regulatory projects.
• Participate in investigations related to complaints to ensure patient and customer safety.

Experience & Education

• Bachelor’s degree in Engineering or related discipline is essential; a focus in Mechanical Engineering is preferred.
• A minimum of 6 months of experience in mechanical product design and development is required.
• Familiarity with biomechanics, biology, and anatomy is advantageous.
• Preferable knowledge of medical device regulations, including GMP, QSR, and ISO quality requirements.
• Understanding of Good Documentation Practice (GDP) is a plus.
• Familiarity with CAD software is preferred.
• Understanding of manufacturing methods, especially machining, is beneficial.
• Experience designing medical devices or working in a machine shop environment is advantageous.
• Experience with plastic injection molding design and manufacturing is preferred.
• Project management experience through co-ops or internships is preferred.
• Demonstrated creative design ability.
• Ability to prioritize tasks and manage a varied workload effectively.

Skills & Knowledge

• Strong initiative and the ability to execute project responsibilities, overcoming obstacles and balancing priorities effectively.
• Excellent communication skills to convey concepts and ideas to various stakeholders.
• Proficiency in the MS Office Suite (Word, Excel, PowerPoint) is required.
• Willingness to work with wet tissues/cadaver and within an Operating Room setting is required.
• Fluent in German and English at a business level.