17 days old

Process Development Engineer II

Danvers, MA 01923
  • Job Code
Careers That Change Lives

A Day in the Life
Develop, characterize, and validate medical device manufacturing processes.
Participate in efforts for design/manufacturing transfer and production release of finished goods and components. This includes BOM/routings and other ERP required information.
Develops 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 processes on various projects and initiatives; communicates with internal and external customers and suppliers at various levels.
Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to develop repeatable and reliable processes.
Identify process technology opportunities and provide technical solutions via analysis and hands-on interaction with designated processes.
Utilize practical project management 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 incorporate DRM and COS principles as new products are being developed.
Provide process training and knowledge transfer as required.

Must Have: Minimum Requirements
Bachelor's degree required with 2+ years of experience or Advanced Degree with 0+ years of experience

Nice to Have
Degree in Engineering
Experience in medical device, pharmaceutical or highly regulated industry
Technical knowledge of manufacturing processes
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)
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.
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)

Posted: 2022-08-02 Expires: 2022-08-31
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Danvers, MA 01923

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