Junior Medical Device Development Engineer

AMARIS GROUP SA; Warsaw, Northern (IN, KY); Hybrid; USD 60,000 - 85,000; Full time

Job summary

Amaris Consulting seeks a Junior Product Development Engineer to support the design, development, and commercialization of medical device products in an on-site environment in Warsaw, Indiana. You will work under supervision with a team to translate user needs into design inputs and help ensure regulatory compliance.

The ideal candidate holds a bachelor's in Mechanical or Biomedical Engineering and has 1–3 years of related experience, with strong problem-solving and communication skills.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 1–3 years of relevant product development experience or internships.
• Understanding of design principles and development processes.
• Familiarity with design verification and validation activities.

Responsibilities

• Support the design, development, and commercialization of medical device products.
• Develop understanding of product use, clinical procedures, and applicable regulations and standards.
• Engage with users and stakeholders to identify needs and market opportunities.
• Translate user and market needs into design requirements and inputs.
• Support creation of product designs and document design rationale.
• Prepare and review technical docs related to invention disclosures and patents.
• Coordinate with cross-functional teams on prototypes production and inspection.
• Support design verification, validation, and process validation activities.
• Develop product specs with manufacturability and inspection considerations.
• Identify critical-to-quality features and support QC plans.
• Perform tolerance stack-up analyses, benchtop testing, and simulated-use evaluations.
• Prepare and support design control and risk management documentation.
• Collaborate with Quality, Sourcing, and Manufacturing on design transfer to production.

Skills

Engineering principles

Design verification

Cross-functional collaboration

Analytical problem-solving

Reading drawings

Communication

Attention to detail

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

CAD software

Engineering analysis tools

MS Office

Job description

Amaris Consulting seeks a Junior Product Development Engineer to support the design, development, and commercialization of medical device products in an on-site environment in Warsaw, Indiana. You will work under supervision with a team to translate user needs into design inputs and help ensure regulatory compliance.

The ideal candidate holds a bachelor's in Mechanical or Biomedical Engineering and has 1–3 years of related experience, with strong problem-solving and communication skills.