Manager, Design Assurance Quality
1 day ago
- Bachelor's Degree in Engineering or related field required
- Master's Degree may offset some experience requirements
- People management experience required - including providing coaching and feedback, responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
- Design Quality or Engineering Management experience in a regulated medical device or life sciences industry required
- You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle
- Your work will involve you optimizing product development to impact patients around the world with pioneering technology
- Work cross functionally with R&D to refine and finalize the design, develop design requirements, perform testing of the design, and qualify the design per the Product Development Process (PDP)
- Lead risk management and usability engineering activities and support the operations team to help develop inspection methods and facilitate successful transfer/launching of robust products
- Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables
- Manage an engineering team for TMTT Design Assurance
- Develop team members to increase business acumen and functional skills
- Identify opportunities and lead the implementation of changes to drive improvements
- Other incidental management duties
- Proactively escalate issues to appropriate levels of management in the organization
- Ability to work and excel within a fast paced, dynamic, and rapidly changing work environment
- Conducts presentations of technical information concerning specific projects and schedules - able to prepare information and provide problem-solving solutions; influence cross functional partners
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
- For California, the base pay range for this position is $115,000 to $162,000 (highly experienced)
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
This role is onsite, based out of the Edwards Global Campus Headquarters in Irvine, CA.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
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