Senior Design Quality Engineer (Mechanical)

Stryker; Portage (MI); On-site; USD 78,000 - 130,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Risk management

Design verification

Design validation

Statistical analysis

Minitab

FMEA

GD&T

Root Cause Analysis

Poka-Yoke

CAD reading

Polymer materials

Six Sigma

Education

Bachelor’s Degree in Mechanical Engineering

Tools

ISO 13485 knowledge

ISO 14971 knowledge

Job description

Work Flexibility:

Onsite Stryker is hiring a Senior Design Quality Engineer (Mechanical) in Portage, Michigan, to support our Medical business. In this role, you will independently execute and own quality engineering activities for defined mechanical workstreams within new product development and partner with cross-functional teams, including R&D, Operations, Manufacturing, Suppliers, Testing, and Regulatory, throughout the development process. You will be responsible for quality activities within assigned products, components, or suppliers, including risk management, design verification and validation, process controls, design transfer, and post-market quality support through the change control process. You may also contribute to and coordinate quality improvement initiatives within your assigned scope.

What you will do

• Partner with R&D to evaluate mechanical product designs against quality requirements for safety, effectiveness, reliability, manufacturability, and usability, and translate customer and market feedback into clear design and quality requirements for assigned workstreams.
• Own risk management deliverables for assigned new product development workstreams, including developing risk management plans and reports, facilitating risk reviews, and verifying the effectiveness of design and process risk controls.
• Execute and coordinate design quality activities for assigned workstreams across requirements, design reviews, drawings, specifications, inspection methods, design verification and validation, and change control to ensure objective evidence supports product acceptance.
• Develop and execute design verification and validation strategies and requirements, including usability activities; review protocols and results; and complete final reports with clear, statistically valid conclusions.
• Partner with Operations and suppliers to develop, evaluate and implement robust manufacturing process controls for assigned mechanical components and assemblies.
• Coordinate product design and quality transfers to internal and/or external manufacturing facilities, including PPAP planning, supplier communication, readiness reviews, and approval of quality documentation.
• Identify and document critical quality attributes within assigned workstreams using risk-based methods and ensure alignment with design outputs and process controls.
• Own PPAP execution for assigned components or suppliers.
• Communicate PPAP requirements to component suppliers, evaluate submission readiness, and approve PPAP documentation and results within the assigned scope.
• Support quality system maintenance and improvement by identifying procedural updates and implementing effective, sustainable solutions.

What you will need

• Bachelor’s Degree in Mechanical Engineering or a related engineering discipline.
• 2+ years’ experience in quality, manufacturing, new product development, or engineering.
• Preferred Experience within the medical device or regulated manufacturing industry.
• Working knowledge of ISO 13485 and ISO 14971.
• Experience with statistical analysis, sampling plans, statistical process control, and Minitab.
• Applied knowledge of Advanced Quality tools such as Failure Modes and Effects Analysis (FMEA), GD&T, tolerance analysis, Root Cause Analysis, and Mistake Proofing/Poka-Yoke.
• Ability to read and interpret CAD models, engineering drawings, specifications, and inspection requirements.
• Knowledge of polymer materials/processes and performance considerations for medical device applications.
• Six Sigma certification or ASQ certification.

United States of America Pay Ranges: USN: $77,700 - $129,500 USD Annual View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.