Development Engineer

Accede Solutions Inc (accedesolution.com); Warsaw (IN); On-site; USD 60,000 - 90,000; Full time

Job summary

Accede Solutions Inc in the United States is seeking a Development Engineer I to support the design, development, commercialization, and sustaining of innovative medical-device products. You will translate user needs into design inputs and assist with prototype production.

You will coordinate Design Verification, Design Validation, Process Validation, and contribute to Design for Manufacturability while documenting CTQ features and supporting design transfer with Quality, Sourcing, and

Qualifications

• ABET-accredited engineering degree required or global equivalent.
• Experience with Medical Devices, Orthopaedics/Arthroplasty, and Product Development.
• Familiarity with Design Controls, Design Verification & Validation, Risk Management, and DFM.

Responsibilities

• Support new product design and development activities.
• Translate user needs into design requirements and inputs.
• Support prototype production and inspection.
• Coordinate Design Verification, Design Validation & Process Validation.
• Develop production specifications with Design for Manufacturability (DFM) considerations.
• Identify and document Critical-to-Quality (CTQ) features.
• Perform tolerance stack-ups and benchtop testing.
• Participate in simulated OR/cadaveric product evaluations.
• Prepare design control and risk management documentation.
• Support design transfer with Quality, Sourcing, and Manufacturing teams.
• Work with cross-functional teams and product users, including Orthopedic Surgeons.

Job description

We are looking for a Development Engineer I to support the design, development, commercialization, and sustaining of innovative medical-device products.

• Support new product design and development activities
• Translate user needs into design requirements and inputs
• Support prototype production and inspection
• Coordinate Design Verification, Design Validation & Process Validation
• Develop production specifications with Design for Manufacturability (DFM) considerations
• Identify and document Critical-to-Quality (CTQ) features
• Perform tolerance stack-ups and benchtop testing
• Participate in simulated OR/cadaveric product evaluations
• Prepare design control and risk management documentation
• Support design transfer with Quality, Sourcing, and Manufacturing teams
• Work with cross-functional teams and product users, including Orthopedic Surgeons

Required Education

Bachelor’s degree from an ABET-accredited school (or global equivalent) in:

Experience with:

• Medical Devices
• Orthopaedics/Arthroplasty
• Product Development
• Design Controls
• Design Verification & Validation
• Risk Management
• DFM
• Prototyping
• GD&T
• Tolerance Stack-ups