Senior Engineer, Advanced Quality (NPD)

Portage - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid or Onsite

Styker 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 guiding new product development teams through internal quality system requirements to launch new products.
You will 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:

Bachelors 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 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 contractors legal duty to furnish information.

Required Experience:

Senior IC

Work Flexibility: Hybrid or OnsiteStyker 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 ...

Work Flexibility: Hybrid or Onsite

What you will do:

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

Bachelors 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 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%

Required Experience:

Senior IC

Key Skills

Quality Assurance
Six Sigma
Design Controls
FDA Regulations
ISO 9001
Minitab
Root cause Analysis
ISO 13485
Quality Systems
Quality Management
As9100
Manufacturing

Apply Now

About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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