Research and Development

Sr. Project Engineer- Fluids

Address: 350 Merrimack St, Lawrence, MA 01843, United States of America

Job ID: R0203034

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As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.

A female nurse examining her patient

Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.

A female nurse examining her patient

Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.

A female nurse examining her patient

Inpatient RNs at Fresenius Medical Care perform dialysis treatments on an acute patient population in a hospital setting, including ICU, ER, Rehab, and Med/Surg units. What makes this role truly unique is the level of autonomy you’ll enjoy. Inpatient nurses are specifically accountable for administering and assessing each patient’s treatment plan. And because dialysis is a critical treatment for many hospital procedures and health conditions, you’ll have the opportunity to work with a wide variety of patients. Ideal candidates possess leadership skills and independence needed to make quick decisions in a fast-paced environment. Must be capable of educating patients and providing exceptional customer service to our partners. Six months to one year of dialysis experience or some form of critical care nursing experience are also required.

A female nurse examining her patient

Job Description

Position Location Details - Upon agreement between you and your supervisor, you are entitled to a flexible arrangement where you will be able to split your time between working from the office and working remotely.

Position Summary 

You will lead and support product and process development project activities related to Fresenius Medical Care fluid products, including parenteral solutions and dialysate concentrate fluid products. This is a newly created position to support growth in Fresenius Medical Care unique portfolio of dialysis fluid offerings.  

 

Specific Duties  

  • Lead major projects, or phases of projects, to resolve advanced and complex technical problems.  

  • Lead product development projects capturing and documenting design inputs and outputs from feasibility through design transfer into manufacturing. 

  • Lead product-sustaining projects related to product design improvements for reliability improvement, cost reduction, usability, meeting standards, manufacturability, or others. 

  • Support design transfer activities between the development team and Fresenius Medical Care manufacturing facilities or 3rd party contract manufacturers 

  • Work with and support Quality Assurance and Research and Development teams to maintain an approved Quality System that complies with GMPs, QSR, and ISO standards. 

  • Work with and support supply chain projects and activities related to maintaining production and on-time deliveries of NxStage dialysis fluid products. 

  • Domestic and international traveling (on an as-needed basis, up to 20% of total time)  

 

Education, Qualifications & Experience 

  • BS in Engineering or Chemistry with 8+ years of experience in product design or manufacturing of parenteral solutions 

  • Project Management Certification (PMP) strongly preferred  

  • MS or MBA preferred  

  • Experience with ISO 13485, ISO 10993, ISO 14971, and ISO 11607 preferred 

  • Experience with ISO 13408 Aseptic Processing a plus  

  • Strong understanding of product and process development of medical devices required with experience in parenteral drugs (USP/EP/BP) preferred  

  • Familiarity with analytical methods, stability study design (ICH Q1A), and microbial testing desirable  

  • Positive can-do attitude and strong leadership skills  

  • Ability to work in a team setting with demonstrated experience working cross-functionally and leading teams to accomplish goals 

  • Excellent interpersonal skills with the ability to fluently communicate technical concepts to all levels within the organization 

  • Ability to manage complexity in a fast-paced environment 

  • Advanced understanding of the entire development process, including specification, documentation, and quality assurance  

  • Experience working with contract manufacturers and suppliers, including outside the United States 

Position Location Details - Upon agreement between you and your supervisor, you are entitled to a flexible arrangement where you will be able to split your time between working from the office and working remotely.

EOE, disability/veterans

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion
“I successfully completed the RN program and went on to hold the position of Staff RN, Charge Nurse, and finally Clinical Manager.”
Rosalyn,
Clinical Manager
“Every day I walk in I am changing lives for the better and working to inspire my patients.”
Andrew,
Patient Care Technician
“I am a member of an outstanding team that helps patients gain more control, achieve tangible goals, and live better lives.”
Tony,
Outpatient Services RN
“My goal is to make sure that our patients keep their mobility and quality of life. This goal is really personal for me. My own father always had really bad vasculature in his leg and never had access to the kind of care we offer — eventually he lost blood flow and mobility. Knowing what he went through makes me even more committed to our mission.”
Warren J.
Azura Regional Vice President

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We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.

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