- 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.
Requirements
- 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., SolidWorks, 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.
Core Competencies
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.
Highest-signal resume keywords
- Mechanical Engineering Degree
- R&D Engineering Experience
- Orthopedic Biomechanics Knowledge
- CAD Software Proficiency
- Regulatory Compliance Familiarity
ATS Optimization Keywords
Hard Skills
- Life Cycle Management
- Design Documentation
- Feasibility Studies
- Verification and Validation Testing
- Finite Element Analysis
Soft Skills
- Problem-Solving
- Collaboration
- Communication
Industry Keywords
- Medical Device Industry
- FDA QSR
- ISO 13485
- Sports Medicine
- Soft Tissue Repair
Tools & Technologies
- SolidWorks
- Pro/ENGINEER
- CAD Software