Manufacturing Engineer II
DescriptionCareers that Change Lives
A key member of the team to lead the technical aspects of New Venture programs. In this exciting role as a Manufacturing Engineer, you will be a key technical team member driving manufacturing engineering efforts for cross-functional New Venture programs.
Transforming diabetes care together, for greater freedom and better health. Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.
New Ventures is focused on developing new diabetes systems, products and solutions in an inorganic, accelerator environment. Our team is unique in that we can adapt to a variety of business, patient and marketplace needs that span the entire spectrum of our product portfolio today and in the future. Our mission drives the need to be a highly skilled, flexible, extremely efficient, versatile and agile in medical device product development for the benefit of our patients with Type 1 and Type 2 diabetes in need of intensive insulin therapy.
The Manufacturing Engineer II is responsible for driving the technical execution for programs that deliver products for patients in need of emerging solutions to help manage their diabetes. This position will work closely with a cross-functional program development team including co-collaborators, outside partners and internal members with expertise from a wide variety of engineering and product development disciplines to transfer designs to production and develop the associated manufacturing processes. Some of these team member disciplines including engineering (mechanical, electrical, firmware, software, manufacturing), marketing, clinical regulatory affairs, quality and other key business functions. In addition, the Manufacturing Engineer will generate technical plans related to these process development and design transfer activities.
A Day in the Life
• Ensure that assigned projects are run in compliance w/ the Design Control SOP or their subordinate DOP’s and Change Control procedures
• Act as an interface and conduit across company-wide functional organizations to meet and coordinate required program timelines
• Interface and assist team members in achieving business unit’s strategic goals and other related program tasks
• Collaborate with internal and external (suppliers, CM’s, OEM’s, etc.) manufacturing and engineering functions to troubleshoot and resolve technical issues, ensuring successful implementation of NPI, product improvement, sustaining EOL and capacity initiatives
• Coordinate and align with cross-functional organizations prioritize, plan and execute key initiatives
• Coordinate and communicates with business functions as needed with respect to supply-related, business continuity initiatives
• Drive product development/quality improvement activities to ensure that products meet cost, yield, and quality targets
• Process various Engineering Changes (ECR/ECO)
• Assist suppliers with manufacturing process and tooling development and validation activities (IQ/OQ/PQ)
• Directly interface with suppliers/CM’s/OEM’s to resolve project related issues
• Comply with all standards and exercise regulatory compliance requirements such as FDA QSR and ISO 13485
• Work with QA and others to identify the risks for appropriate management and mitigation when addressing Engineering issues.
Responsibilities may include the following and other duties may be assigned.
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions.
May incorporate inspection and test requirements into the production plan.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensures processes and procedures are in compliance with regulations.
Required Education and years of experience:
• Bachelor’s degree in Engineering, Biomedical, or Sciences.
Nice to Have
• 2+ years of engineering
• Project management experience
• Plastic processing and component assembly process experience
• Background in medical device/pharmaceutical/aerospace industry.
• Experience in a regulated manufacturing industries.
• Working knowledge of CAD software (AutoCAD and Solidworks)
• Lean Six Sigma experience.
• Experience using document control software such as Agile.About Medtronic
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)