Orthopedic Medical Device Design Engineer

Amaris Consulting; Warsaw (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Amaris Consulting is seeking a Design Engineer for its R&D team in the medical devices sector. You will work with surgeons, Manufacturing, Quality, and Regulatory groups to translate clinical needs into robust orthopedic device designs.

You will contribute to design verification/validation, risk management, and documentation, supporting the path from concept through production transfer. Collaboration with cross-functional teams is essential.

Qualifications

• ABET-accredited B.S. in one of the listed engineering disciplines.
• 1–3 years of product development or related engineering experience.
• Familiar with CAD, GD&T, tolerance analysis, design verification/validation, and risk management.

Responsibilities

• Engage with clinicians and users to identify needs and translate them into design requirements.
• Create product designs and document design rationale.
• Prepare invention disclosures and support patent documentation.
• Coordinate cross-functional teams to produce and inspect prototypes for DVT/validation.
• Develop production specifications for DFM and inspection requirements.
• Identify critical-to-quality features to inform QC inspection plans.
• Execute design verification/validation activities including tolerance stack-ups and benchtop testing.
• Prepare design control and risk management documentation for approvals.
• Support transfers to manufacturing and supplier onboarding.

Skills

CAD

GD&T

Risk management

Cross-functional collaboration

Education

ABET-accredited BS in Mechanical Engineering or related field

Job description

Amaris Consulting is seeking a Design Engineer for its R&D team in the medical devices sector. You will work with surgeons, Manufacturing, Quality, and Regulatory groups to translate clinical needs into robust orthopedic device designs.

You will contribute to design verification/validation, risk management, and documentation, supporting the path from concept through production transfer. Collaboration with cross-functional teams is essential.