Senior Engineer, Manufacturing USA - Utah – Salt Lake City Full time Req-51784

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world. This Senior Engineer will support and sustain the manufacturing of THV delivery systems, with a strong emphasis on continuous improvement. This role involves leading and collaborating with various teams to enhance manufacturing processes, improve product quality, and ensure operational efficiency. Heavy focus will be put on lean manufacturing and continuous improvement. How you'll make an impact: Identify and lead implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.) Lead and Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in Engineering with a minimum of 4 years experience including either industry or industry/education OR Master's Degree or equivalent in Engineering with a minimum of 3 years experience including either industry or industry/education OR Ph.D. or equivalent in Engineering with industry experience or industry/education What else we look for (Preferred): Lean Six Sigma belt certification PMP certification Experience working in the medical device industry or another highly regulated manufacturing environment Experience with Root Cause Analysis (RCA), Nonconformance Reports (NCRs), and Corrective and Preventive Actions (CAPAs) Ability to manage multiple priorities and deliver results in a fast-paced manufacturing environment. Proven ability to work independently and exercise sound engineering judgment. Proficiency with Microsoft Office Suite, including Excel, PowerPoint, and Project. Knowledge of applicable FDA regulations and quality system requirements. Experience with CAPA systems, nonconformance investigations, audit support, change control, and risk management processes. Experience applying Design of Experiments (DOE), statistical process control (SPC), process capability analysis, and hypothesis testing. Experience supporting process validation and equipment qualification activities. Experience leading cross-functional manufacturing improvement projects with measurable business impact. Experience supporting new product transfers, equipment implementation, or manufacturing technology integration. Experience working with complex manufacturing equipment and automated production systems. SHARE THIS JOB Job reference Req-51784 Apply Now Type Full time Category Engineering Location USA - Utah – Salt Lake City Posted for 11 hours ago SHARE THIS JOB Apply Now About Edwards Lifesciences Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. ‌ What we offer Diversity, inclusion & belonging Find out more Our benefits Find out more Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds. Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.