Senior Process Development EngineerCareers that Change LivesAt Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. The Senior Process Development Engineer will lead the development of advance manufacturing technologies for new products and therapies. This position will work with other functions within the program team; but will have ownership for plans, reports, data collection, or other means necessary to gain the knowledge required to create and document the associated manufacturing procedures. You will also collaborate with design colleagues to ensure designs are capable of meeting performance and manufacturing targets. This position will support in data collection and review of regulatory submission-ready documentation for the FDA and other regulatory bodies. The PVH operating unit offers a diverse portfolio of devices and therapies to treat restore the right blood flow to the right patient.Peripheral Vascular Health therapies treat patients with Peripheral and Carotid Artery Disease, End-Stage Renal Disease, Superficial and Deep Venous Diseases, and a variety of conditions treated with Peripheral Embolization. The operating unit leads the way in the Superficial Venous, Deep Venous Stenting, and Drug-Coated Balloon markets, caring for nearly 1 million patients globally with lifesaving and life-enhancing therapies.This position is in Santa Ana, CA. within the Peripheral Vascular Health (PVH) operating unit and requires on-site presence.We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.A Day in the Life In general, the following responsibilities apply for the Senior Process Development Engineer. This includes, but is not limited to the following:·Support new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective products with optimized yields.·Pilot Line Development: Design manufacturing sequence of operations/workflow and specifications for equipment/tooling to ensure most efficient and productive layout.·Feasibility Studies: Perform feasibility studies that explore new process technologies and evaluate its potential for application to catheter manufacturing. Analyze results and make recommendations.·Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations. Design and develop equipment and fixture requirements and its process parameters where applicable. Work with suppliers and internal stakeholders to realize design and ensure it meets specified requirements.·Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Develop plans to evaluate process capability. Perform test method development and validation. Apply six sigma methodologies as appropriate.·Defines and generates all required documentation in support of manufacturing products and processes. These includes designing and writing engineering protocols in compliance with GMPs and internal procedures, FMECAs, reports, manufacturing instructions and procedures. Use of appropriate six sigma methodologies such as Design of Experiments (DOEs), Gage R&R, and other statistical tools as necessary. Provides in depth analysis of issues or problems and implements process improvements to enhance performance of the job area.·Collaborates with product development teams to support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields. Communicates with senior internal groups and frequent interaction with external groups (i.e. vendors, suppliers, etc.).·Develops cost benefit analyses and implements process improvements initiatives to reduce and/or optimize product costs.·Domestic and international travel anticipated up to 10%.Required Qualifications·Bachelor's degree in Engineering, or a technical discipline·Minimum of 4 years of work experience in Engineering, OR Advanced degree in Engineering, or technical discipline with 2 years of work experiencePreferred Qualifications ·Advanced degree in engineering or equivalent technical discipline·Experience in medical device manufacturing or manufacturing in highly regulated industry/environment·Catheter device manufacturing experience·Prior knowledge and experience in new product development·History of successfully transferring projects to manufacturing·Prior knowledge and experience in AutoCAD/Solidworks in drafting plant layouts, fixtures, engineering drawings, etc·Demonstrated solid interpersonal skills and ability to work in a team environment.·Green Belt Certified·Black Belt Certified·Six Sigma training·Project management experience·Working knowledge of statistical tools such as DOE, SPC, Hypothesis Testing and Process Capability Studies·Minitab and Design Expert skills (DOE and other statistical analysis)·Experience with polymer extrusion, reflow, thermal bonding, and adhesive bonding·Familiarity with DMAIC/A3 problem solving approach·Understanding of DFSS and DFM activities in the early phase of new product design·COS conversion knowledge and experience·Proficient in Microsoft OfficeAbout MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.? We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here. This position is eligible for a short-term incentive plan.? Learn more about Medtronic Incentive Plan (MIP) here.The provided base salary range is used nationally (except in certain CA locations).?The rate offered is compliant with federal/local regulations and may vary by experience,?certification/education, market conditions, location, etc.? Base pay is based on numerous factors and may vary depending on job-related?knowledge, skills, and experience.
