Senior Project Manager (R&D, Design Controls) - HYBRID
CyberCoders

Job Info

Senior Project Manager (R&D, Design Controls) - HYBRID Located in Chicago, IL & Southwest Michigan, we are a global leader in medical technology that is listed as one of the World's Best Workplaces and a Best Workplace for Diversity!

Our last Senior PM was promoted, so we are actively looking for a replacement!

This role is a Divisional (Medical) lead for Design Controls. This person will be at the heart of developing the product and tell regulators following it that it is in compliance with regulations stated in QMS. This role will be the divisional process owner as well as Kalamazoo's site process owner and will work directly with the site process owners (7 total). No direct reports - they will manage the process and drive improvements/change by working directly with R&D and RAQA to provide leadership and direction to ensure we have best-in-class Design Control systems and methods that will be employed across all Medical R&D sites.
Top Reasons to Work with Us - Competitive Comp DOE ($100-150k base ballpark depending on experience)
- 10% Annual Bonus
- Medical, Dental, Vision, 401K, Stock-based plans
- PTO, Sick leave, Holidays, Parental leave
- Stable organization with a great track record of career growth, cutting edge tech, and employee retention
- Tuition Reimbursement
- Real R&D on products that help save lives and enable better care
- Opportunity to work both independently and as part of a larger team with various levels of responsibilities
- Ability to partake in our campus and all it offers
- Sponsorship approved

*We are located in Kalamazoo, MI, and Cary, IL!
- If candidates reside in Cary, IL, he/she will be expected to travel to Kalamazoo biweekly to be onsite a few days and be present
- Travel is paid for by the company & relocation is provided upon request*
What You Will Be Doing * Kalamazoo, MI Site Process Owner (SPO) for products (beds, stretchers, mattresses, temp management, cots, chairs)

* Maintain the design controls process /drive improvements for these products

* Look at design files, represent in audits, and connect with corporate process owners for bringing changes into Kalamazoo

* DPO (Divisional Process Owner) for all of Medical (this will take a while to develop yourself)

* As DPO, you will supportsite owners on other sites.  All sites have their own SPOs and products (wipes, ICU disposables, mattress turn solutions, and physio products like defibrillators, chest compression devices, and data solutions)

* The ideal candidate will have R&D/product launch experience, a strong engineering foundation, and potential quality background

* This person should be able to influence without authority and have global exposure

* You will learn about R&D/Quality across all business units within the division (high visibility role)

* You will have exposure to all products within the division and will increase efficiency across the division (continuous improvement)

What You Need for this Position Minimum Qualifications:
* Bachelor's degree in an engineering discipline required

* 6+ years of relevant experience

* Strong background in R&D / Quality Systems / Design Controls experience required (FDA preferred)
 
Preferred Qualifications:

* Experience in the medical device SDLC

* Demonstrated versatility and a willingness to influence and lead a team

* Excellent communication, teamwork, conflict management, and negotiation skills

* Ability to build relationships and influence at all levels

* Ability to mentor, train, and develop team members

.

So if you are a Senior Project Manager or Program Manager with Engineering / R&D / Design Controls experience, please apply today!

For immediate consideration, please email caroline.veillon@cybercoders.com with your relevant experience and the best time + number to reach you!

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- Applicants must be authorized to work in the U.S.



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