We anticipate the application window for this opening will close on - 27 Nov 2024

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Research, plans, designs, verifies, validates, and develops mechanical and electromechanical products and systems, such as metals, instruments, controls, plastics, robots, engines, machines, and mechanical, resonance, hydraulic, or heat transfer systems for production, transmission, measurement, and use of energy.

• Interact with personnel on significant technical matters, often requiring coordination between organizations.

• Identifies and oversees testing required to obtain necessary data to support field actions, regulatory renewals, submissions, and deficiency responses.

• •Provide a critical evaluation of manufacturing and supplier change impact on fielded products

• Initiates change activity (CA) to modify and maintain design documentation (BOMs, Specs, drawings)

• Supports CAPAs (Corrective & Preventive Actions) and RPIs (Released Product Investigations), including possible CAPA ownership

• Provide RPE input to new product development teams 

• Assists Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals.

• Supports IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications

• Collaborates with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes before implementation 

• Collaborates with reliability, manufacturing, materials, and R&D to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s)

• Assists manufacturing sites with lean layout initiatives, interfacility transfers, and outsourcing

• Supports cost reduction and continuous improvement projects

• Provides problem-solving/troubleshooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost

• Supports internal and external regulatory compliance audits

• Actively participates in new product development to RPE transfers; ensures completion of all transfer deliverable

Required Knowledge and Experience: 
Requires a Baccalaureate degree

Minimum of 2 years of relevant experience

Nice to have

• Proficient knowledge of ablation deviation and Stimulator and leads
• Working level understanding of implantable procedures, clinical use conditions, new indications, competitive product landscape & state-of-the-art industry status
• Proficient knowledge of medical device industry standards, regulations, and compliance requirements
• Basic knowledge of mechanical processes, materials, processes, PFMEA and DFMEA
• Demonstrates good judgment about issue escalation and consultation with other SME’s
• Able to work independently and exercise appropriate latitude when addressing abstract, yet-to-be-defined technical issues and problems

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
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