We anticipate the application window for this opening will close on - 5 Dec 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

The Senior Release Analyst (RA) works independently to prepare, process, and implement quality systems, configuration assurance, and product design documentation deliverables to support Neuromodulation and Pelvic Health Labeling and Packaging components (i.e., manuals, instructions for use (IFUs), cards, package labels, package configurations, etc.) and Product Release end items. This individual coordinates with a team to facilitate, release, and control Neuromodulation and Pelvic Health electronic manuals on the Medtronic eManuals websites.

• Configuration Management:

  • Coordinates with Product Release and Configuration Assurance to prepare and route Engineering Change Orders and Change Actions (CO/CAs).

  • Fulfill internal customer requests for electronic versions of labeling.

  • Review parts prior to CO/CA release to ensure that all requirements for end item components and specifications are met, escalating issues as necessary.

  • Create and maintain end items in a product lifecycle management (PLM) system.

• Quality System:

  • Coordinate with Product Release and Quality Systems to prepare and route product design documentation.

  • Perform audits of labeling and packaging components.

  • Perform proofs of labeling components and print vendor labeling.

  • Ensure personal understanding of all quality policy/system items that are applicable. 

  • Follow all work/quality procedures to ensure quality system compliance and high-quality work.

  • Support the development and facilitation of training for tools, processes, and best practices with internal partners.

• eManuals Release:

  • Perform the eManuals Release Administrator (ERA) role by staging and releasing manuals to the eManuals website for the operating unit, including specifying the attributes.

  • Lead activities surrounding the qualification and release of eManuals for product launches.

  • Participate in user acceptance testing for the eManuals website as needed.

  • Follow established editorial guidelines for populating the attributes of eManual records on the eManuals website.

  • Participate in requirements definition and testing for new features on the eManuals website.

  • Facilitate troubleshooting resolution with internal and external partners related to content, quality, or schedules. 

  • Provide subject matter expertise to support enhancements to the eManuals website.

  • Participate in an eManuals working group to establish requirements for delivering content electronically.

• Product Release:

  • Analyze and verify requirements for Unique Device Identification (UDI) registration.

  • Coordinate deliverables and activities required for product release, including Device Master Record (DMR) indexing.

  • Analyzes metrics that provide data for process measurement, identifying indicators for future improvement opportunities.

  • Contributes to diagrams and evaluates existing processes.

  • Collects data to identify root cause of problems.

  • Measures performance against process requirements.

  • Surveys and analyzes best practices for techniques and processes.

  • Perform other related tasks as assigned.

Must Have (Minimum Requirements)

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree with 4+ years of job-related experience, OR

• Master’s degree with 2+ years of job-related experience

Nice to Haves (Preferred Qualifications):

• Strong experience working in a regulated environment.

• Strong experience working in a medical device environment.

• Demonstrated experience working with FDA, ISO, EN, and/or GMP standards.

• Proven, strong detail-oriented work skills.

• Proven ability to easily adapt to multi-task and shift priorities effectively and expediently.

• Demonstrated proficiency with common software packages (e.g., Word, Excel, Adobe Reader).

• Proven ability to easily adapt to and master proprietary programs.

• Demonstrated ability to work independently and with a team.

• Proven ability to train and mentor others.

• Excellent interpersonal skills, particularly the verbal skills necessary for communicating with multiple individuals and groups of stakeholders, often under deadline pressure.

• Demonstrated involvement in process definition and improvement.

• Experience working with outside suppliers for services such as for printing and web development.

• Experience with printing and publishing of technical documentation.

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
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Salary ranges for U.S (excl. PR) locations (USD):$86,400 - $129,600

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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.