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.