Senior Manager, Design Quality
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Stryker is hiring a Senior Manager Design Quality in Irvine California! In this role youll lead a sizable high-performing team of Design Quality Engineers who are shaping the future of medical technology. Youll guide and support their efforts on high-impact new product development (NPD) projects ensuring design requirements are met and manufacturing processes are optimized to deliver life-changing solutions to patients!
What You Will Do:
Drive talent strategy by attracting developing and retaining top engineering talent while fostering a culture of growth and high performance.
Lead high-complexity projects from concept to execution managing budgets timelines and staffing to meet business goals.
Ensure technical excellence by overseeing design control activities for new and existing products and processes guiding teams through risk management (e.g. FMEA) and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO 13485.
Lead continuous improvement initiatives to enhance quality system effectiveness productivity and cost efficiency across engineering processes.
Drive achievement of key engineering and quality metrics including product quality performance on time design deliverables and timely closure of NC/CAPA actions.
Influence cross-functional collaboration with Regulatory Marketing Clinical Operations and Finance teams to align technical strategies with business goals and customer needs.
Partner with customers and key opinion leaders (KOLs) to develop technical strategies that align with clinical and business needs.
Contribute to financial strategy by managing project-level budgets and supporting broader R&D financial planning.
What You Will Need:
Required Qualifications
Bachelors degree in engineering or a related technical discipline.
Minimum 10 years of experience in engineering or a related technical field.
Experience in the medical device industry.
Minimum 5 years of people management experience.
Strong knowledge of design controls risk management test method validation and quality concepts (including CAPA audits and statistics).
Preferred Qualifications
Advanced degree (MS or PhD) in engineering or a related technical field.
Certifications such as Six Sigma Black Belt ASQ CQE or ASQ CRE.
Experience with full lifecycle medical device development from concept through launch.
Experience executing talent development and performance management strategies.
Experience working in complex compliance or riskbased environments
$155900.00 - $259800 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors
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 Manager
Key Skills
- Lighting Design
- FileMaker
- Mobile Marketing
- Sketchup
- Relationship Management
- Adobe Photoshop
- Autocad
- Adobe Illustrator
- Team Management
- Revit
- Experience Design
- Grasshopper
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
