Job Description
We are seeking a dedicated team member to assist in the design and development of innovative implants and instrumentation while also supporting existing products throughout their life cycle. This role involves collaboration across various departments to ensure successful product outcomes.
Key Responsibilities
- Assist in the design and development of new implants and instrumentation.
- Collaborate with design engineering, marketing, quality, supply chain, manufacturing, regulatory affairs, and Health Care Professionals (HCPs) to establish functional and design requirements and product concepts for both new and existing products.
- Support lead R&D engineers in developing conceptual models, drawing layouts, prototypes, verification and validation methods, and required Design Control documentation.
- Contribute to documentation and Design Control activities ensuring compliance with MDR and FDA Design Control regulations to facilitate 510(k) submissions and/or IDE clinical studies.
- Design with consideration for manufacturing and inspection processes.
- Engage in mechanical test design, execution, and documentation.
- Maintain a comprehensive understanding of existing product lines and relevant anatomic injuries/pathologies and treatment options.
- Support assigned technical tasks as needed.
- Follow the New Product Development (NPD) process while maintaining high-quality design verification and validation practices.
- Engage with clinicians to inform design development and support clinical assessments of improvements and modifications.
- Complete necessary documentation to support design and process changes, demonstrating proficiency in applying design controls and development processes.
- Understand the IP process, supporting initial patent reviews and freedom-to-operate (FTO) assessments.
- Contribute to operations projects, including cost improvement initiatives and production transfers.
- Adhere to all applicable laws and policies, maintaining the highest standards of professionalism, ethics, and compliance.
- Participate diligently in compliance program-related activities as directed by the supervisor or the Chief Compliance Officer.
- Promote and nurture high standards of professionalism, ethics, and compliance while supporting the Code of Business Conduct and compliance initiatives.
- Participate in quality and compliance activities, including audits, remediation projects, nonconformances, and regulatory compliance projects.
- Engage 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.
- Familiarity with 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.
- Experience with CAD software is preferred.
- Understanding of manufacturing methods (especially machining), mechanisms, materials, tolerancing, drafting standards, and geometric dimensioning and tolerancing (GD&T) is preferred.
- Experience in designing medical devices and/or working in a machine shop environment is preferred.
- Background in 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.
- Ability to prioritize tasks and manage a diverse workload effectively.
Skills & Knowledge
- Strong initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively.
- Excellent communication skills - ability to effectively convey concepts, ideas, and knowledge to upper management, customers (including Health Care Professionals), and teams across the organization.
- Proficiency in utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required.
- Willingness to work with wet tissues/cadaver and within an Operating Room setting is required.
- German: Business fluent.
- English: Business fluent.
How to Apply
Apply online using the form below. Only applications matching the job profile will be considered.