JobsUSASenior Engineer, Advanced Quality (NPD)
Company : Stryker
Location : Portage, MI, 49002
Posted Date : 15 September 2025
Job Details
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.
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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.
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You will lead risk management for projects, including risk analysis and development of sound mitigation strategies.
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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.
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You will help lead Human Factors Engineering activities to develop intuitive and safe new products.
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You will lead design validation efforts to ensure new products meet all customer user needs.
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You will support process validation for new product development to ensure long-term product quality.
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You will develop and create procedures for incoming, in-process and final inspection of components and finished goods.
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You will evaluate project tangibles for technical competence and compliance to ensure we are delivering robust products.
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You may lead NC & CAPA, which require expertise in problem solving and root cause analysis.
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What you need:
nRequired:
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Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or equivalent discipline is required.
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2+ years of experience in a Technical Engineering or Quality Engineering role within an R&D or manufacturing environment.
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Preferred:
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Previous experience in a regulated environment. Experienced in Medical Device manufacturing with strong familiarity in ISO 13485, GDP, and GMP standards.
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ASQ CQE, CRE, CSSBB or equivalent course work / experience desirable
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Knowledge or certification in GD&T preferred
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Understanding of Med Device manufacturing processes
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Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
nStryker 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.
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