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19 days old

Medical Device Project Manager

Kelly Services
St Louis, MO 63103
**Job Title** : Medical Device Maintenance of Business - Project Manager


**Full Time Direct Hire or Contract:** Full Time / Direct Hire


**On-Site or Remote or Hybrid :** 100% Onsite


**Managerial Reporting and Responsibilities:** There are no direct reports for this position.


**Work Location:** St, Louis, MO.


**Position Summary:** The Medical Device Maintenance of Business (MOB) Project Manager is responsible for managing MOB business critical projects aligned with the St. Louis Surgical Equipment Manufacturing site priorities. The MOB projects ensure continuity of supply, provide enhanced product quality and support manufacturing cost improvements. This position will receive primary technical direction from the Surgical Equipment Portfolio Lead in Rochester, NY and from the R&D Engineering leadership at the St. Louis manufacturing facility in St. Louis MO.


**Specific Job Duties:**


1. Work with the site R&D and Operations leadership to identify and a prioritize Maintenance of Business projects in support of St. Louis surgical equipment manufacturing based on the following criteria:


+ Priority 1: Non-Conformance (NC), CAPA, Compliance, Product Recall, Customer Complaints, Critical Manufacturing Issues

+ Priority 2: Manufacturing Supply Chain Continuity (e.g. obsolete components)

+ Priority 3: Risk Mitigation (e.g. alternative sourcing of critical components)

+ Priority 4: Manufacturing Efficiency and Process Improvement, Cost Reduction (CIP).


2. Develop project resource plans, budgets, schedules and support annual operating plan budgetary activities and resource management associated with project execution.


3. Monitor and report on the overall projects cost performance against plan and manage MOB projects within budget.


4. Ensure project plans and timelines are in place for all planned activities including a detailed project charter/scope, risk assessment, and milestone schedule.


5. Manage process to accommodate new MOB requests and make appropriate trade-offs (e.g. schedule delays) with currently active projects as needed.


6. Chair regular management reviews and updates of progress against annual project goals and deliverables and communicate changes to project priorities and timelines.


7. Develop close working relationship with site leads and R&D resources to ensure alignment and balance of MOB project resource needs with other site and R&D projects.


8. Lead individual MOB projects within the project portfolio as appropriate.


9. Ensure project documentation is completed and approved per procedures. Where necessary generated required report writing and documentation for DHF.


10. Responsible for initiating and managing Quality Change Requests (QCRs) to completion.


**Qualifications and Requirements:**


**Education:** Bachelor degree in Mechanical Engineering, Chemical Engineering, Material Science, Chemistry, Physics, or related discipline. PMP certification and Masters Degree a plus, but not required.


**Work Experience:**


1. Knowledge and experience in medical device manufacturing processes.

2. Ability to be successful within a matrix-reporting environment.

3. Technical and managerial experience within an FDA regulated industry.

4. Demonstrated experience with lean techniques and principles preferred.

5. Demonstrated use of 6-Sigma skills and DOE skills highly desirable.

6. An ability to analyze and manage technical issues across multiple technical disciplines.

7. Strong leadership capabilities.

8. Excellent project management, organizational, and documentation skills

9. Proven track record of delivering to objectives.

10. Significant change management experience.

11. Technical transfer experience and an understanding of manufacturing.

12. Strong teamwork and negotiation skills and the ability to influence without authority.

13. Demonstrated ability to work across organizational boundaries.

14. Excellent communication skills and ability to influence at all levels of the organization.

15. Excellent verbal, writing and computing skills. Familiar with MS Office, MS Project, CAD and statistical evaluation software.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-06-10 Expires: 2022-07-11

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Medical Device Project Manager

Kelly Services
St Louis, MO 63103

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