4 Hot Jobs for Monday: St. Jude Medical (Plano, TX)

Here's four of my hottest jobs on tap for our Neuromodulation Division in Plano, TX:

Director, Electrical Engineering
Financial Analyst
Regulatory Affairs Specialist
Sr. Machine Design Engineer

Apply online - feel free to email me if you have any questions.

MDR Specialist (Post Market Vigilance) - St Jude Medical, Plano, TX

MDR Specialist (St. Jude Medical) Apply Online

The MDR (Medical Device Review) Specialist manages, maintains, and tracks customer complaints through the Quality Systems Database in accordance with Site procedures and regulatory agencies, specifically, 21 CFR Part 820, 198, Complaint Files, and 21CFR Part 803, Medical Device Reporting

Software Development Manager - Plano, TX

Software Development Manager
St. Jude Medical - Neuromodulation Division
Plano, Texas

Miss the Virtual Job Fair?

If you missed today's virtual job fair and would like a copy of the presentation, email me HERE.

Thanks to all attendees who dialed in today! We had terrific questions and our managers provided an excellent overview of the skill sets and the kinds of people that would be a great fit in our Product Development team. We'll be hosting another job fair soon so stay tuned:

Director of Strategic Supplier Operations (St. Jude Medical - Plano, TX)

I have an urgent requirement that's so hot off the press, it hasn't even hit the career page of our website.  But it will.  Today.

Director of Strategic Supplier Operations
St. Jude Medical - Neuromodulation (NMD)
Plano, Texas

This key leadership role will add dedicated technical muscle and operational know how to NMD’s cross functional supplier management team. Initially, it will be an individual contributor position reporting to NMD’s VP of Operations. Role is accountable for driving targeted operational excellence at select critical suppliers in a way that directly and measurably benefits NMD. He/she will be positioned with these suppliers as their primary, and most senior, business, technical, operations liaison. This skilled individual will be required to quickly and thoroughly assess production plant effectiveness, operating systems, cultures, management and key personnel to determine areas for focused improvement.

On Birthday Cookies and Pittsburgh Steelers

Good times today in Plano, TX today (esp since we started the morning out around 20 degrees). That makes for some cold toes on the kitchen floor - gotta find my slippers.

Besides the fact that we got to polish off the rest of yesterday's BIRTHDAY COOKIES (see the lone cookie stage left - and thank you, Julie!), we also managed to find the time to hire an incredible Territory Manager for AZ (yes, you know who you are, and yes, we are lucky).

And I reached out to seven terrific prospects for our Sr. Manager, Continuous Improvement role (somebody call me back!). Just remember, if I don't hear from you, I'll be back.

I managed to squeeze in some mega-sourcing for our new Sr. Quality Engineer position. Reminder: if you are strong electrical (hardware/firmware) background and your are currently in the med device industry - we need to talk.

And finally, don't give up on me (to all those who've shown interest in the Sr. Manager, Fellows Program)! This one's taking a little extra time, but we should be able to make some progress next week. Fingers crossed.

Hey, it's Friday. Enjoy the playoffs as they resume this weekend, and for the sake of our VP (who has his reputation on the line with a way-crazy wager), Roethlisberger better bring his A-game.

Go Jets.

Senior Manager, Continuous Improvement - Post Marketing Quality

Terrific opportunity just opened in our Quality team and it posted to our career site today.

Reporting to the Director of Post Marketing Quality, the Senior Manager, Continuous Improvement will serve as the CI Subject Matter Expert, and lead our division's efforts to improve productivity and increase St Jude Medical's bottom line.

Here's a few of the responsibilities you'll have while leading a team of CI Engineers:

Senior Manager, Fellows Program (St Jude Medical)

Apply Online

Sr. Manager, Fellows Program - St. Jude Medical

A candidate we’ll love: 

• You have a strong history of success, driving future sales and impacting future market share gains through early customer relationship development, brand identification, and product adoption. 
• You connect at all levels, and passionately cultivate relationships with institutional program directors and industry key opinion leaders (fellows/directors). 
• You enjoy talking strategy and big picture as much as products and service. 
• You have an impressive record of creating and implementing pain, neurosurgery, PMR and orthopedic sales and marketing initiatives throughout the United States, specific to health care professionals in training/fellows.
• You have a track record of identifying program ‘champions’ within the sales organization to implement sales initiatives and liaise with program directors and fellows.
• You’re well versed in the medical device industry, and have the ability to develop and execute strategies to familiarize fellows with SJM products during their program.
• You are a strategic thinker, and collaborate in the design of fellows marketing pieces, and the design of HCP in training and fellows professional education courses.
• You have expert verbal and communication skills.
• You have the ability, and the willingness, to travel extensively.
• You’re a strategic thinker, and have spent the past 5+ years in the medical device industry focused on marketing, training, and field work.
• You’re a difference-maker.

Last Call! QE Virtual Job Fair (St Jude Medical)

Here's the first slide for tomorrow's "Quality Engineering" Virtual Job Fair (St. Jude Medical).

For more details, or to register, please click HERE!

1st Ever Virtual Job Fair (at St Jude Medical - Neuromodulation)!

Quality Engineer - Mechanical (St Jude Medical) Plano, TX

Apply Online

As a key member of the Quality Engineering team, the QE, ME acts as a quality representative on cross-functional project teams to:

• assess risks/hazards associated with product designs, processes and applications
• create quality – related documentation for project design history files
• develop and execute product tests and validations
• analyze resulting data, and document results, and 
• develop and implement processes and procedures.
   

Senior Quality Engineer (EE) St Jude Medical - Plano, TX

Apply Online

The Senior Electrical Quality Engineer assures that electrical devices and firmware meets all regulatory and voluntary standard requirements. This includes participation in the design validation process and review of schematics and designs. Final product verifications and validations may also be included. Risk assessment is a key component of this position.

Telecommunications Analyst (Plano, TX)

Telecommunications Analyst (Plano, TX)
St Jude Medical

Apply Online

(click on the "apply online" link above, then scroll 1/2 way down page to see this specific job)

This Corporate position is located in our Dallas (Plano) office.

*key requirements:  Cisco Unified and Cisco Call Manager experience key

Senior Software Analyst Manager

Senior Software Analyst Manager
St Jude Medical - Plano, TX

Apply Online

Check out the details of this post to see the primary job responsibilities for this role:

#BecauseofTwitter, I Post Too Many Jobs...

...but hey, it's an awesome #job ~ scout's honor:

Manager, Quality Engineering (Electrical/Firmware/Software) St Jude Medical (Plano, Texas)

Four Jobs for Friday @ St Jude Medical

Four (4) jobs I'm focused on today ~ click the link to look at a more detailed job description (once it takes you to our career site, scroll down the page to view the specific job title and description you are looking for):

Manager, Quality Engineering Apply Online

Product Analysis Engineer Apply Online

Auditor Apply Online

Quality Engineer, Mechanical Apply Online

Four Jobs for Friday @ St Jude Medical

Four (4) jobs I'm focused on today ~ click the link to look at a more detailed job description (once it takes you to our career site, scroll down the page to view the specific job title and description you are looking for):

Manager, Quality Engineering Apply Online

Product Analysis Engineer Apply Online

Auditor Apply Online

Quality Engineer, Mechanical Apply Online

Auditor, St Jude Medical (Plano, TX)

Apply Online

Auditor, St Jude Medical - Plano, TX
Educate, advocate, and support QA and compliance operations ensuring that all applicable global Quality System laws, and regulations, together with business internal operating procedures, are identified, interpreted, communicated and applied without compromise by all concerned company employees and throughout the entire product development lifecycle.

Major, On-Going Responsibilities: 
•Assist Audit Manager with development, management and execution of the NMD Audit program
•Establish and implement Master audit schedule with assistance and direction from Audit Manager
•Lead quality system audits to ensure the Global Quality Management System operates in a state of compliance
•Remain current on all regulatory environment changes and facilitate implementation to ensure compliance as required
•Develop and/or improve a system of metrics for the Audit program
•Complete, monitor, analyze, and present Audit data and trending to ensure quality system issues are identified, addressed and resolved
•Report to Audit Manager, potential systemic quality system issues through the analysis of quality data such as CAPAs, complaints, MDR, NCMR, Audit reports, etc
•Help interpret Regulatory requirements in a current regulatory environment and provide guidance and direction on the development, revision and/or maintenance of the quality system and business processes in compliance to applicable laws and regulations
•Verify and ensure compliance with the company's policies and procedures as well as Global Regulatory Requirements, such as FDA 21 CFR part 820, 803, 806, ISO 13485, AIMD, Canadian MDR, Brazil, Australia, Japanese regulations and other global regulations as appropriate.
•Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
•Identify Quality Audit Initiatives and lead cross-functional teams to complete them
•Communicate with Regulatory Agencies upon direction from management on compliance related issues, reporting, or activities


Experience & Training:
•Minimum 3 years relevant work experience with quality assurance, quality systems, or quality engineering in the regulated (FDA) industry
•Minimum 3 years experience in a medical device, pharmaceutical or biotechnology industry.
•Minimum 3 years experience with Audits or Quality systems.
•Minimum 3 years experience applying regulations (including FDA QSRs, ISO13485)
•Auditor certification required
•Ability to work independently in fast-paced environment with little supervision
•Ability to creatively problem solve to achieve effective resolution
•Ability to communicate effectively (both written and oral)
•Team-oriented and responsive to customer needs
•Strong problem solving and analytical skills
•Quality focused, attentive to detail and results oriented
•Ability to influence positive change effectively
•Ability to build strong relationships
•Proficient with software programs to facilitate data analysis work
•Knowledge of FDA CFR part 820, 803, 806 ISO 13485:2003, CMDCAS, AIMD, Japan Ministerial ordinances and other global quality system regulations
•Project Management experience a plus

Other Skills/Characteristics: 
•Strong attention to detail
•Influencing – champion initiatives that generate organization-wide understanding and support
•Problem Solving – establish resources, processes to gather information/data for problem solving or analysis
•Excellent communication skills, including written, verbal and interpersonal
•Decisiveness and judgment based on data and sound reasoning
•Ability to work independently with minimal supervision
•Takes initiative to perform tasks that benefit the organization

Apply Online

Software Services Engineer - St Jude Medical (Plano, TX)

Apply Online

Software Services Engineer 
Provides services that support core software engineering activities including analysis of field issues, development of tools, and verification of products

Major Ongoing Responsibilities:
•    Contributes to quality and process improvement initiatives; leverages and practices software industry best practices; follows corporate and department processes and policies
•    Assists in the development of standard operating procedures and work instructions pertaining to software engineering; coordinates review and approval of procedure changes; prepares and delivers associated training
•    Designs, implements, and deploys processes, tools, and software support systems
•    Manages software licenses, renewal of support agreements, tracking of license needs, software downloads and library
•    Leads the evaluation, selection, validation, and deployment of new software engineering tools
•    Maintains existing tools including configuration and administration, upgrades and serves as point of contact with vendors
•    Participates in the resolution of customer issues that are escalated to R&D
•    Assists in the analysis of returned products through interaction with technical service, customer service, service department, and reliability departments
•    Performs complaint investigations
•    Develops product support guides and technical troubleshooting instructions to assist customer service department
•    Provides feedback regarding product support and maintainability back to development for design improvements
•    Maintains a thorough knowledge of products

Education and Training:
•    Bachelors or Masters degree in computer science, computer engineering, electrical engineering, or a related field Minimum 3 years experience as a software development or support engineer preferably in the medical device industry
•    Expertise with system and modern software engineering methodologies
•    Understanding of fundamental electronics principles
•    Familiarity with test and lab equipment such as oscilloscopes, voltmeters, etc.
•    Knowledge of standards (IEC, IEEE, etc.), regulations (CFR 21, etc.), guidances, and best practices applicable to software engineering and medical devices
•    Experience with HP Quality Center for requirement, defects, and test management
•    Experience in software test automation including the development of automated test frameworks and automation of existing manual test cases (minimum 2 years experience with QuickTest Professional (QTP))
•    Mastery of C# preferred
•    Excellent interpersonal and communication skills both written and verbal

Manager, Quality Engineering - St Jude Medical

Apply Online

Manager, Quality Engineering (St Jude Medical) Plano, TX

Electrical/Software Quality Engineering Manager directs a group of 5 to 10 engineers that are focused on electrical, software, and firmware quality engineering.  They will lead a group that are responsible for assuring that electrical devices, firmware, and software developed for use or sale at SJM NMD meets all regulatory and voluntary standard requirements. This includes providing guidance to a group of engineers with experience ranging from 5 years to 25 years.

Major, On-Going Responsibilities: 
•    Identify and develop talent to take on larger roles and improve product and system quality
•    Perform performance reviews
•    Provide guidance on performance of job function to direct reports
•    Ensure that all requirements are met for product development, operations, and risk management activities
•    Lead group of highly skilled product experts and drive data-driven decisions throughout the organization

Experience & Training: 
•    Bachelors degree in Engineering, Science, or related field
•     10 to 20 years quality assurance or quality engineering background is required
•    Experience with medical device or regulated industry is required
•    Experience with formal development methodologies and design is recommended
•    Experience with risk management and ISO 14971 familiarity is a definite plus
•    Must have minimum of 2 years management experience
•    Good written and verbal communication skills. Must work well within a cross-functional team environment.

Must be capable of working with minimal supervision.  Must be able to work on several projects simultaneously.  Must be able to supervise direct reports in effective manner.

Please apply online by following this link:  Apply Online

Once you get to the St Jude Medical career site, scroll down to find the Manager, QE position.