Senior Product Engineer

Medtronic - Mounds View, MN (30+ days ago)4.0


Careers that Change Lives:
Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

A Day in the Life:
The Senior Product Engineer serves as a subject matter expert by providing leadership and Sourcing support for the new product development and sustaining projects both in Post Market and Pre-Market space. The individual will act as a subject matter expert and provide guidance to the business and the external suppliers in executing against Medtronic Quality system elements as required to ensure compliance. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality and compliance requirements. This individual will ensure Sourcing-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.

You are a self-motivated person, determined to succeed.
You have strong analytical and conceptual thinking, working through the details while seeing the big picture.
You have a desire to learn and improve the current technology and processes, driving for creative solutions and sustainable results.
Your top responsibility is for the quality of our products which support the monitoring and follow up of patients with implanted cardiac devices.
You understand the importance of product performance, functions, and product use environments to appropriately and strategically apply technical knowledge to drive the suppliers Manufacturing requirements and improvements
You work collaboratively with Design Engineering, Development, Test Engineering, Regulatory Affairs, and other cross-functional partners
As a team member, you’re also responsible for continuous improvement and ensuring we have industry-leading practices.
You lead process improvement projects and develop shared best practices to drive functional excellence

Roles and Responsibilities:

• Understands therapy (clinical) performance, disease states, product function(s), and product use conditions to appropriately and strategically apply supplier selection, development, component and finished product qualification and production control plans.
• Define supplier objectives, Design and Manufacturing requirements, partner with suppliers to ensure components are designed and manufactured for reliability, manufacturability, and cost reduction via component and finished product specifications. Ensure supplier feedback is included in the development process.
• Previous Medical Device Manufacturing experience is preferred with proven abilities to establish, communicate, implement and execute on Remediation initiatives to ensure the Mfg. meets the Regulation and Medtronic requirements for Compliance and Patient safety.
• Define component and finished product qualification strategy, partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component and Finished good engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.
• Drive supplier requirements and supplier performance objectives by collaborating effectively with Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.
• Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. Resolve components/material failures and focus actions on the root cause. Assure compliance to procedures and timely completion of CAPAs and audit findings.
• Responsibilities include Project Management and leading cross-functional improvement initiative teams, leading Design for Manufacturability and Assembly (DFMA) thinking and work practices to demonstrate functional excellence.
• Understanding of Manufacturing Process: advantages/disadvantage of various manufacturing methods for different commodity types, manufacturability, assembly, relation to design specifications, up and down requirements flow, traceability, and process control
• Ability to interpret and contribute towards Engineering Process: design intent, risk management, therapeutic & design functionality, develop qualify & implement controls
• Class II and III medical devices and regulations to include ISO13485, ISO9001 and FDA CFR.
• Utilizing development protocols including Installation Qualification (IQ), Operational Qualification (OQ), a Performance Qualification (PQ), Special Process Validations, and Test Method Validations (TMV).
Responsibilities may include the following and other duties may be assigned.
  • Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; and optimizing device production relative to cost constraints.
  • Assumes responsibility for device after transfer into high-volume production and usually responsible for entire device manufacturing operations other than wafer fabrication.
  • May assist customer in device usage problems or customer testing of complex devices.

Requirements
- Bachelor’s Degree in Electrical Engineering or Mechanical Engineering, Reliability Engineering, Systems Engineering or other Technical Discipline
- Four (4) or more years of experience (with Bachelor's) or Two (2) or more years (with Master's)
- Deep understanding and application of Installation Qualification (IQ), Operational Qualification (OQ), a Performance Qualification (PQ), Special Process Validations, Test Method Validations (TMV), Control Plans, Risk Management (DFMEA, PFMEA), External regulations and standards to include ISO13485, ISO9001, ISO 14971 and FDA CFR 21 part 820.
Nice to Have:
Medical Device Industry experience a plus

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 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 Day in the Life 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.