· 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 (HCPs) 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 (FTO) 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. Experience & Education: · 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 (e.g., through a college co-op, internship, or research) is required. · Knowledge of biomechanics, biology, and anatomy is a plus. · Knowledge of medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality System Regulation), and ISO quality requirements, is preferred. · Knowledge of GDP (Good Documentation Practice) 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. Skills & Knowledge: · 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. · Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required. · Willing to work with wet tissues/cadaver and within an Operating Room setting is required. · German: Business fluent · English: Business fluent