Mechanical Design Engineer, Orthopedic Implants Position Available In Cumberland, Maine
Tallo's Job Summary: ALM Ortho, Inc. is currently hiring a full-time Mechanical Design Engineer for Orthopedic Implants in Scarborough, Maine. The role involves supporting the development of bone-anchored osseointegration implants and devices, designing, prototyping, and validating orthopedic products within FDA and ISO-compliant Quality Management Systems. Candidates must have a Bachelor's in Mechanical Engineering, 5+ years of medical device product development experience, proficiency in SolidWorks CAD software, and knowledge of FDA and ISO regulations. Additional experience with additive manufacturing and biomechanics is preferred.
Job Description
Mechanical Design Engineer, Orthopedic Implants at ALM Ortho, Inc.
Mechanical Design Engineer, Orthopedic Implants at ALM Ortho, Inc. in Scarborough, Maine
Posted in Other 24 days ago.
Type:
full-time
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 ISOpliant 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, andpliance.
Support additive manufacturing processes for titanium orthopedicponents, 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,munication 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.
