Development 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

Join a leading global medical technology company's R&D team to design and develop new orthopedic medical devices — from concept to commercialization. You'll work cross-functionally with surgeons, Manufacturing, Quality, and Regulatory teams to bring innovative arthroplasty products to market for an organization recognized as a market leader in joint replacement technology.

What You'll Do

(With mentorship from senior engineers and oversight from your supervisor)

• Engage with product users — often orthopedic surgeons — to identify unmet clinical needs and observe device usage in context
• Translate user needs into design requirements that meet business goals while complying with global regulatory standards
• Create product designs and author design rationale documenting the basis for design decisions
• Prepare invention disclosures and support patent documentation
• Coordinate cross-functional teams to produce and inspect prototypes for design verification and validation
• Develop production specifications accounting for design for manufacturability (DFM) and inspection requirements
• Identify and document critical-to-quality features to inform quality control inspection plans
• Execute design verification/validation activities: tolerance stack-ups, benchtop testing, and simulated OR cadaveric evaluations
• Author and present design control and risk management documentation for cross-functional approval
• Support Quality, Sourcing, and Manufacturing teams during design transfer to production

What You Bring

• B.S. from an ABET-accredited program (or global equivalent) in: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical/Bioengineering Technology, Aerospace Engineering, or Aeronautical Engineering
• 1–3 years of relevant experience in product development, mechanical/biomedical engineering, or a related engineering function
• Familiarity with product development fundamentals: CAD, GD&T, tolerance stack-up analysis, design verification & validation, risk management
• Exposure to design control processes and NPD (new product development) workflows
• Strong collaboration skills — you'll work closely with surgeons and multiple internal functions

A plus, not a requirement:

• Experience in medical devices, orthopedics/arthroplasty, or joint replacement
• Familiarity with FDA regulations, ISO 13485, or design control documentation
• Any exposure to surgeon-facing product development

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.