1+ months

Principal Process Development Engineer - Automation

Fridley, MN 55432
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Principal Process Development Engineer - Automation


Fridley, Minnesota, United States

Requisition #:


Post Date:

Nov 09, 2021

**Careers that Change Lives**

In this role, you will be responsible for identifying manufacturing technologies, vendors and processes to support the development of implantable combination products (medical device and pharmaceutical combined devices). As part of the Process Development team, you will work with cross-functional teams to design and procure highly complex, automated equipment to meet the needs of the development program. You will be the key link in bringing new products from prototype manufacturing into high-volume production. Using your expertise in process and equipment design, you will coach, review, and delegate work to lower level professionals to support equipment and process development within the Interventional Vascular Structural Heart (IVSH) operating unit.

Engineers create our market-leading portfolio of innovations. Combine the best of your experience with training and mentorship to move forward. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide.

You can grow your career with us; we hope youll consider joining our team!

**A Day in the Life**

Identify technologies that meet the manufacturing needs of new product development programs

Define design criteria and author associated documentation including User Requirements Specifications and Equipment Specifications for highly automated equipment

Oversee vendor design and fabrication of automated manufacturing equipment

Lead the definition and execution of the Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and process characterization.

Represent the organization as a primary technical contact for specific projects and initiatives with vendors; communicates with internal and external customers and suppliers at various levels

Lead efforts for production release of finished goods and components. This includes BOMs/routings and other ERP required information.

Develop solutions to complex problems, and/or makes moderate to significant improvements of processes, systems or product independently to enhance performance of the area

Manage major/complex projects, involving delegation of work and review of work products, at times acting as a team leader

Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve and control the mfg line and select processes

Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes

Utilize project mgmt skills to drive process development, vendor adherence to program schedules, 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 drive back lessons learned as new products are being developed

Provide training and certification for trainers as required

Lead efforts to investigate and develop new technology related to combination products

**Must Haves**

Bachelors Degree and 7+ years of Engineering experience OR advanced Degree and 5+ years of Engineering experience

**Nice to Have**

Experience in medical device, pharmaceutical or highly regulated industry

Experience in the design and specification of highly automated manufacturing equipment

Understanding of a wide application of technical principles, theories, and concepts of manufacturing processes including robotics, spraying systems, and laser cutting

Technical knowledge of high volume and highly complex manufacturing processes

Experience handling multiple tasks concurrently

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)

Excellent 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

Excellent technical writing skills

**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. Lets 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)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Posted: 2021-11-11 Expires: 2022-02-18
Sponsored by:
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Principal Process Development Engineer - Automation

Fridley, MN 55432

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