Senior Mechanical Design Quality Engineer (Remote-Friendly)

Stryker; Portage (MI); Presencial; USD 78 000 - 130 000; Tempo integral

Resumo da oferta

Stryker in Portage, Michigan is seeking a Senior Design Quality Engineer (Mechanical) to lead quality activities for defined mechanical workstreams in new product development, partnering with R&D, Operations, Manufacturing, Suppliers, Testing and Regulatory.

You will own risk management deliverables, design verification and validation, process controls, design transfer, PPAP, and post-market quality support through the change control process, with opportunities to drive quality improvements

Qualificações

• Bachelor’s degree in Mechanical Engineering or related field.
• 2+ years’ experience in quality, manufacturing, new product development, or engineering.
• Preferred experience in medical device or regulated manufacturing.
• Working knowledge of ISO 13485 and ISO 14971.
• Experience with statistical analysis, sampling plans, SPC, and Minitab.
• Knowledge of FMEA, GD&T, tolerance analysis, RCA, and Poka-Yoke.
• Ability to read CAD models, drawings, specs, and inspection requirements.
• Knowledge of polymer materials/processes for medical devices.
• Six Sigma or ASQ certification.

Responsabilidades

• Partner with R&D to evaluate mechanical designs against quality requirements.
• Own risk management deliverables for new product development workstreams.
• Coordinate design quality activities across requirements, reviews, drawings, specs, inspection methods, V&V, and change control.
• Develop and execute design verification and validation strategies and reports.
• Collaborate with Operations and suppliers on manufacturing process controls.
• Coordinate product design and quality transfers to facilities, including PPAP planning and supplier communication.
• Identify critical quality attributes and ensure alignment with outputs and controls.
• Own PPAP execution for components or suppliers.
• Communicate PPAP requirements and approve documentation and results.
• Support quality system maintenance and improvements.

Conhecimentos

Risk management

Design verification

Design validation

Statistical analysis

Minitab

FMEA

GD&T

Root Cause Analysis

Poka-Yoke

CAD reading

Polymer materials

Six Sigma

Formação académica

Bachelor’s Degree in Mechanical Engineering

Ferramentas

ISO 13485 knowledge

ISO 14971 knowledge

Descrição da oferta de emprego

Stryker in Portage, Michigan is seeking a Senior Design Quality Engineer (Mechanical) to lead quality activities for defined mechanical workstreams in new product development, partnering with R&D, Operations, Manufacturing, Suppliers, Testing and Regulatory.

You will own risk management deliverables, design verification and validation, process controls, design transfer, PPAP, and post-market quality support through the change control process, with opportunities to drive quality improvements