Position Overview:
We are seeking a talented and driven Mechanical Design Engineer to join our Product Development team. In this role, you will support the development and optimization of bone-anchored osseointegration implants and associated devices. You will work closely with cross-functional teams to design, prototype, and validate cutting-edge orthopedic products within FDA and ISO-compliant Quality Management Systems (QMS).
Key Responsibilities:
- Contribute to the design and development of new and existing orthopedic implants, particularly osseointegration solutions.
- Generate detailed 3D models and technical drawings using SolidWorks CAD software.
- Participate in risk analysis, verification and validation testing, and design reviews.
- Collaborate with clinical, regulatory, and manufacturing teams to ensure product safety, functionality, and compliance.
- Support additive manufacturing processes for titanium orthopedic components, including design for additive manufacturing (DfAM) principles.
- Maintain design history files (DHF), device master records (DMR), and technical documentation in alignment with FDA regulations and ISO 13485:2016 standards.
- Assist with root cause investigations and corrective/preventive action (CAPA) efforts.
- Conduct research on materials, biomechanics, and implant-tissue integration to inform design decisions.
- Support product lifecycle activities including design changes, updates, and post-market surveillance.
Required Qualifications:
- Bachelor's in Mechanical Engineering or related field.
- 5+ years of experience in medical device product development, preferably orthopedic implants.
- Proficiency in SolidWorks 3D CAD software.
- Experience working within FDA QSR and ISO 13485 regulated environments.
- Hands-on experience with additive manufacturing of titanium or other metallic medical implants.
- Experience with traditional manufacturing methods (machining, finishing, coatings) and similar technologies.
- Strong understanding of biomechanics, materials science, and implant design principles.
- Excellent problem-solving skills, communication abilities, and a detail-oriented mindset.
Preferred Qualifications:
- Familiarity with surgical workflows and clinical environments.
- Working knowledge of design controls, risk management (ISO 14971), and regulatory submission processes.
- Experience with finite element analysis (FEA) or simulation tools.