Senior Engineer, R&D

• Lead life cycle management activities of sports surgical and shoulder reconstruction products, ensuring alignment to project timelines and regulatory requirements.
• Be a critical member of multi-functional teams including product managers, quality assurance, regulatory, and manufacturing.
• Leverage CAD software, prototyping techniques, and feasibility studies to craft and iterate on implant and instrument concepts, considering factors such as biomechanics, material properties, and manufacturability.
• Generate and maintain detailed design documentation, including design history file requirements, specifications, drawings, test protocols, and risk documentation in compliance with regulatory requirements and internal standards.
• Design and conduct feasibility and verification and validation testing to ensure design concepts meet user needs and design requirements.
• Provide technical support to manufacturing teams addressing design-related issues and optimizing manufacturing processes.
• Stay abreast of industry trends, new technologies, and competitive landscape to advise product development strategies and find opportunities for innovation.

• A minimum of a Bachelor's degree in mechanical engineering, biomedical engineering, or bioengineering;
  Master's degree preferred.
• 5 years of experience in R&D engineering within the medical device industry; experience in sports medicine soft tissue repair preferred.
• Strong knowledge of orthopedic biomechanics, anatomy, and physiology, with a demonstrated ability to apply principles to product design and development.
• Proficiency in CAD software (e.g., Solid Works, Pro/ENGINEER) and experience with finite element analysis (FEA) software.
• Familiarity with regulatory requirements and standards governing medical device development, including FDA QSR and ISO 13485.
• Excellent problem-solving skills and ability to work independently as well as part of a cross-functional team.
• Strong communication skills, with the ability to effectively collaborate with internal and external stakeholders.
• Passion for innovation and a desire to make a positive impact on patient care.

Demonstrates expertise in life cycle management of medical devices, particularly in sports surgical and shoulder reconstruction products, with a strong foundation in orthopedic biomechanics and regulatory compliance. Proficient in CAD software and experienced in conducting feasibility studies and validation testing to ensure product efficacy and safety.

• Mechanical Engineering Degree
• R&D Engineering Experience
• Orthopedic Biomechanics Knowledge
• CAD Software Proficiency
• Regulatory Compliance Familiarity

• Life Cycle Management
• Design Documentation
• Feasibility Studies
• Verification and Validation Testing
• Finite Element Analysis

• Problem-Solving
• Collaboration
• Communication

• Medical Device Industry
• FDA QSR
• ISO 13485
• Sports Medicine
• Soft Tissue Repair

• Solid Works
• Pro/ENGINEER
• CAD Software