Staff Engineer, Advanced Quality, R&D, Neurosurgical
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Flexibility: Hybrid or OnsiteTravel Percentage: 10%
Position summary
Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. Lead risk management activities to ensure the highest level of product and process quality.
Key areas of responsibility
- Develop quality assurance documentation to support new product development process and regulatory submissions.
- Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
- Partner with cross-functional project teams to lead product and/or process design and development activities.
- Lead risk management activities for new product development projects.
- Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
- Present risks associated with the product use during Design Reviews and track the design documentation and manufacturing process mitigate those issues throughout the development process.
- Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
- Partner with Advanced Operations in the development of manufacturing processes for new products.
- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits establish process parameters resolve quality problems etc.
- Develop review and approve inspection plans routers and product drawings for new products.
- Support product design transfers to internal and/or external manufacturing facilities.
- Provide support and direction for other Quality Engineers.
- Evaluate predicate products for relevant quality issues tthat may impact new product development projects.
- Analyze and define critical quality attributes for product and process through risk analysis techniques.
- Participate in collection of initial market feedback on new products and address early concerns.
- Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
Education / work experience
- BS in a science engineering or related discipline.
- MS CQE or CRE preferred.
- Six Sigma Green or Black belt preferred.
- Minimum of 4 years experience preferred.
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Required Experience:
Staff IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
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
