Senior Engineer, Advanced Quality

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Senior Engineer, Advanced Quality to support Instruments-Neurosurgical! In this role, you will lead quality engineering initiatives for new product development, driving efforts in reliability engineering, human factors engineering, risk management, and design validation, all while ensuring compliance with FDA Quality System Regulations and ISO 13485 standards.

What you will do:

• You will be the voice of Quality in a cross-functional team, helping to guide new product development teams through internal quality system requirements to launch new products.

• You will help lead risk management for projects, including risk analysis and development of sound mitigation strategies.

• You will use quality engineering tools, statistical methods, design development methods, process development and control methods, and design verification and validation planning to build quality into new products during development.

• You will help lead Human Factors Engineering activities to develop intuitive and safe new products.

• You will lead design validation efforts to ensure new products meet all customer user needs.

• You will support process validation for new product development to ensure long-term product quality.

• You will develop and create procedures for incoming, in-process and final inspection of components and finished goods.

• You will evaluate project tangibles for technical competence and compliance to ensure we are delivering robust products.

• You may lead NC & CAPA, which require expertise in problem solving and root cause analysis.

What you need:

Required:

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or equivalent discipline is required.

• 2+ years of experience in a Technical Engineering or Quality Engineering role within an R&D, quality, or manufacturing environment.

Preferred:

• Previous experience in a regulated environment. Experienced in Medical Device manufacturing with strong familiarity in ISO 13485, GDP, and GMP standards.

• ASQ CQE, CRE, CSSBB or equivalent course work / experience desirable

• Knowledge or certification in GD&T preferred

• Understanding of Med Device manufacturing processes

Travel Percentage: 10%

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.