Director Fluids Disposable Development & Sustaining Engineering - NxStage - Fresenius Medical Care Holdings, Inc.

Position Summary:

As the Director Fluids Disposable Development & Sustaining Engineering, you will play a key role in the design, development, testing, documentation, and launch of NxStage Medical’s fluids disposable products. You will lead and support product development and sustaining engineering activities including providing direct operational and leadership support to the manufacturing operations teams.  You will lead an internal team of project engineers and provide cross-functional leadership to prioritize efforts and resources between internal and external teams.

 Responsibilities:

• Lead product development, sustaining engineering and operations teams and projects. 
• Deliver project results that support progress on key NxStage product development initiatives. 
• Recruit, retain, and develop excellent product development and sustaining engineering team. 
• Support initiatives that lead to the achievement of NxStage business objectives. 
• Ensure that product development activities conform to applicable design control and risk management requirements. 
• Investigate and implement corrective actions as applicable to design elements of products.
• Ensure that the product development team engages with other functions to participate in complaint trending, investigation, and response as needed
• Manage cross-functional prioritization and design execution of development & sustaining engineering projects

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.  

Education, Qualifications & Experience:

• Strong communicator who values collaboration and teamwork and thrives on working in a dynamic, fast passed environment.
• B.S. in Engineering or Chemistry with 10+ years of experience in product design or manufacturing of parenteral solutions
• Project Management Training (PMP) is strongly preferred 
• MBA preferred 
• Working knowledge of GMPs and QSR.
• Working knowledge of manufacturing economics such as IRR, COGS, etc.
• Experience with ISO 13485, ISO 10993, ISO 14971, and ISO 11607 preferred
• 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. 
• 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 entire development process 
• Working knowledge of the design of experiments is preferred.

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

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.