Senior Controls Engineer (Sensor Manufacturing) @ Medtronic - Northridge, CA

Senior Controls Engineer (Sensor Manufacturing)

Medtronic
Northridge, CA
9 days ago
CAREERS THAT CHANGE LIVES:
Medtronic Diabetes is looking for a Senior Controls Engineer. This position is responsible to support the Sensor Operations team for both process development and scale up of manufacturing. This position is responsible for the specification, development, characterization, and support of reliable, robust and efficient manufacturing and test equipment for Sensor Operational excellence. This position will also participate in process equipment and test instrumentation projects associated with manufacturing continuous improvement and cost down initiatives.
Diabetes

DIABETES BUSINESS DESCRIPTION:
The Diabetes Group is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes; so people with diabetes can enjoy greater freedom and better health.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Click here to see an overview of the products in our Diabetes product portfolio.

A DAY IN THE LIFE:
In this role, the Senior Controls Engineer is responsible for collaboratively partnering with cross-functional teams, external equipment builders and contract manufacturers in the successful development of various manufacturing processes to support the goals and objectives of Medtronic according to strategic plans; working with various functional teams to acquire project resources, scope, and requirements. The Sr. Controls Engineer is also responsible to execute against team manufacturing process development and scale-up automation projects ensuring that
timeline milestones commitments are delivered on time meeting all requirements.

  • You will design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
  • You will design arrangement of machines within plant facilities to ensure most efficient and productive layout.
  • You will design sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
  • You will adapt machine or equipment design to factory and production conditions.
  • You will be responsible to incorporate inspection and test requirements into the production plan.
  • You will inspect performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • You will develop manufacturing processes that are applicable to statistical process control, and may develop those techniques.
  • You will provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • You will ensure processes and procedures are in compliance with regulations.
  • You will provide technical solutions and improvements to manufacturing processes that employ a wide range to
technologies such as but not limited to electroplating, membrane coating, laser processing, automated testing, semi-automation equipment, and
electro-mechanical assemblies
  • You will be able to drive through challenges to deliver on commitments with limited supervision. Communicate clearly in verbal, written, and graphical formats. Ability to multi-task and manage programs.
  • You will have in depth understanding of Medical standards such as FDA 21 CFR Part 11, FDA CFR Part 820, ISO 14971,
ISO 13485, ISO 9001, CMDCAS/CMDR. Understands medical device requirements for software validation, Installation Qualification (IQ), Operation Qualification (OQ) and Process Qualification (PQ) as it relates to production equipment validation.
  • You will have working knowledge of Programmable Logic Control (PLC), servo & linear motor motion control and machine vision (e.g. Cognex) automated inspection methods.
  • You will demonstrate passion for driving innovation, process capability and delivering results that serve patient and business need. Effectively listens to others by asking clarifying questions that gain understanding of other points of view. Views and communicates change as a way of life and ameliorates others’ resistance to change.
  • You will command respect though knowledge and living the Medtronic Mission and Core Behaviors
Must Have: Minimum Requirements
BASIC MINIMUM QUALIFICATIONS
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
Bachelor's degree in an Engineering discipline with 4 years of experience, OR an advanced degree degree with 2 years of experience.

NICE TO HAVE:
  • Strongly prefer degree in electrical engineering or control systems
  • Strongly prefer FDA experience in either direct role in medical device/biopharma or consulting work on medical device/biopharma project
  • National Instrument LabVIEW proficiency
  • Demonstrated proficiency in development of product requirements into machine User Requirement Specifications (URS) that mitigate patient risk through pFMEA traceable URS risk mitigations
  • Knowledgeable in the understanding and development of software validation plan and reports
  • Strong verbal and written communication and presentation skills
  • Experience in applying Good Automated Manufacturing Practices (GAMP-5) to machine design
  • Experience in legacy PLC platforms
  • Experience in developing equipment for use in an ISO-5 clean room environment

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.
  • 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, communicate with peers and co-workers, and sit for prolonged periods of time doing computer based work.
  • Employee must occasionally lift and/or move up to 20 pounds.
  • The noise level in the work environment is usually moderate.
  • Typical office and lab working environments.

ABOUT MEDTRONIC
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.

We can 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.

EEO STATEMENT
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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:
http://www.uscis.gov/e-verify/employees

DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.