Careers that Change Lives
As a member of the R&D Mechanical Engineering Department in the Product Innovation Organization, the individual selected for this role will be responsible for product, process, and technology development activities of diabetes related products such as multiple daily injection (MDI) management, insulin pumps, glucose sensors, and related accessories. The Sr. Mechanical Design Engineer will play a lead role in the product and process development activities including process characterization, design verification, factory acceptance testing and design transfer of diabetes products. The individual will have significant ability to influence on technology and process development as new products are conceptualized.
The person filling this role will become part of a dynamic and fast paced R&D group with a strong history of successful product development. They will have the opportunity to interface with vendors and end customer, as well as various functional groups within the diabetes business unit.
The ideal candidate for this position has had experience in medical device design and development, with an emphasis on new product introduction, research and development, and design/manufacturing transfers. This individual has experience in medical plastics and electromechanical assemblies. The ideal candidate has a solid background in process design, development and qualification including Test Method Validation (TMV). This individual is experienced in performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R). This position will work across the organization driving and collaborating with functions in Design, Development, PMO, Operation, Quality and Regulatory and serve as a liaison externally with contract manufacturers and vendors to assure the successful execution of business goals.
A Day in the Life
Researches, plans, designs, verifies, validates and develops mechanical and/or electromechanical products and systems.
Recommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs.
Present technical findings or project status to cross functional teams and management through meeting minutes, design reviews, presentations and other means of communication.
Lead product and process development activities of diabetes management products.
Lead and perform process characterization, design verification / testing, and Test Method Validation (TMV) activities.
Be the primary point of contact with external vendors, and a Core Team Member for the Mechanical Department/Project team.
Work closely with strategic partners and vendors to support current products and initiate new production projects and assists in developing processes/techniques to meet contract objectives.
Travel to vendor locations and manufacturing sites as needed to help ensure programs meeting deadlines and troubleshoot issues.
Perform Statistical analysis (DOE, Capability Analysis, GR&R ...)
Apply methodologies such as Design for Reliability and Manufacturing (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA) and Cell Operating System (COS) during process design and development phase.
Help develop specifications, test methodologies, and test equipment to evaluate design concepts.
Perform calculations, analyses, and engineering testing to verify the designs. Document results in reports and laboratory notebooks.
Influence on equipment selection, tooling and fixture development, procurement, installation and qualification.
Design, build, and execute testing of components or sub-assemblies; document and present test plans.
Develop and validate test methods and inspection methods.
Help ensure designs meet and exceed product specifications, regulatory requirements, and international standards.
Design / develop components to be manufactured via plastic injection molding, stamping, machining, extrusion, and related processes. Work with manufacturing to consider high volume assembly processes in design concepts.
Provide technical feasibility assessments.
Lead design reviews and ensure on-time completion of Design Control deliverables.
Create and release engineering drawings, written procedures and Bill of Materials.
Work with suppliers to ensure components meet design requirements & diagnose design problems.
Must Have: Minimum Requirements
B.S. in Mechanical Engineering or other engineering disciplines
Years of Experience:
Nice to Have
Process development, characterization and validation of medical devices and sub-assemblies
Experience designing and developing assembly processes and mechanical assemblies
Experience 3D modeling software, i.e. SolidWorks and/or ProEngineer
Experience performing Statistical analysis (DOE, Capability Analysis, GR&R ...)
Test Method Design, development, and Validation
Understanding of medical device design controls.
Experience designing and developing electromechanical assemblies (Drug Delivery Systems or Continuous Glucose Sensors)
Formal training in Six Sigma or DRM Green Belt or Black Belt
Ability to use structural finite elements software such as Ansys or COSMOSWorks
Experience with design for volume manufacturing
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)