Mechanical Design Engineer, Orthopedic Implants Job at ALM Ortho, Inc., Scarborough, ME

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  • ALM Ortho, Inc.
  • Scarborough, ME

Job Description

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.

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