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In this role, you will be responsible for evaluating, improving, and controlling the overall performance of manufacturing areas that provide implantable components and finished devices (including combination products). You will lead and interact closely with the Process Development team as well as Operations, Quality, Reliability Engineering, and Regulatory Affairs. You will provide a key link in introducing new processes into manufacturing and will understand and provide technical solutions to product performance issues. You will coach, review, and delegate work to lower level professionals and will support Cardiac Rhythm and Heart Failure (CRHF) Fridley Operations.
CRHF seeks candidates who will meet our customer's expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action.
Engineers create our market-leading portfolio of innovations. Combine the best of your experience with training and mentorship to move forward. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide.
You can grow your career with us; we hope you'll consider joining our team!
A Day in the Life
- Develop, characterize and validate medical device manufacturing processes.
- Lead efforts for production release of finished goods and components. This includes BOM's/routings and other ERP required information.
- Develop solutions to complex problems, and/or makes moderate to significant improvements of processes, systems or product independently to enhance performance of the area
- Represent organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and suppliers at various levels
- Manage major/complex projects, involving delegation of work and review of work products, at times acting as a team leader
- Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve and control the mfg line and select processes
- Lead failure analysis and issue resolution activities to ensure preventative action is accomplished
- Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes
- Utilize project mgmt skills to drive process development and validation projects to completion; on time and on budget
- Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions)
- Work with product development engineering to drive back lessons learned as new products are being developed
- Provide training and certification for trainers as required
- Lead efforts to investigate and develop new technology related to combination products
- Bachelor's Degree and 10+ years of Engineering experience OR advanced Degree and 8+ years of Engineering experience
Nice to Have
- Experience in medical device, pharmaceutical or highly regulated industry
- Understanding and wide application of technical principles, theories, and concepts of manufacturing processes
- Technical knowledge of manufacturing processes
- Experience handling multiple tasks concurrently
- Work experience with the following: FDA Quality System Regulations, ISO 13485, ISO 9001 standards or equivalent
- Experience with leading/executing process validation activities (installations qualifications, process characterization, operational and performance qualifications)
- Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
- Experience with design of experiments (DOE), process failure mode and effects analysis (PFMEA) and control/monitoring plans
- Excellent technical writing skills
Together, 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 Requirements
The 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)
Valid through: 6/7/2021