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

We are seeking a Junior Product Development Engineer to support the design, development, and commercialization of innovative medical devices. This role will contribute to new product development initiatives as well as the maintenance and improvement of products already available on the market.

Working under the guidance of a supervisor and senior team members, the successful candidate will collaborate with cross-functional teams throughout the product development lifecycle, from identifying user needs to design verification, validation, and transfer to manufacturing.

Key Information

• Location: Warsaw, Indiana, USA
• Work Mode: On-site
• Experience Level: Junior (1–3 years)

Key Responsibilities

• Support the design, development, and commercialization of medical device products.
• Develop an understanding of product intended use, clinical procedures, and applicable regulations and industry standards.
• Engage with product users and other stakeholders to help identify user needs and market opportunities.
• Translate user and market needs into product design requirements and inputs.
• Support the creation of product designs and document the rationale behind design decisions.
• Prepare and review technical documentation related to invention disclosures and patents.
• Coordinate with cross-functional teams on the production and inspection of prototypes.
• Support preliminary product evaluations, design verification, design validation, and process validation activities.
• Develop product specifications with consideration for manufacturability, process capability, and inspection requirements.
• Identify and document critical-to-quality product features and support the development of appropriate inspection and quality control plans.
• Perform engineering evaluations, including tolerance stack-up analyses, benchtop testing, and simulated-use evaluations.
• Prepare and support design control and risk management documentation in compliance with internal procedures and applicable global regulatory requirements.
• Collaborate with Quality, Sourcing, and Manufacturing teams to support design transfer activities and the transition of new products into production.

Profile

Must-Haves

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 1–3 years of relevant engineering experience, including internships, co-ops, or professional experience in product development or a related field.
• Understanding of engineering design principles and product development processes.
• Familiarity with design verification and validation activities.
• Basic knowledge of risk management and design control processes.
• Ability to interpret engineering drawings and technical specifications.
• Strong analytical and problem-solving skills.
• Ability to work effectively within cross-functional teams.
• Strong written and verbal communication skills.
• Good organizational skills and attention to detail.

Nice-to-Haves

• Experience in the medical device industry.
• Exposure to orthopedic or arthroplasty products.
• Familiarity with FDA, ISO, or other global medical device regulations and standards.
• Experience with CAD software and engineering analysis tools.
• Knowledge of tolerance stack-up analysis and design for manufacturability.
• Exposure to prototype development, benchtop testing, or product validation activities.
• Experience supporting manufacturing or design transfer processes.

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.