Job ID 20000L0U
Available Openings 1
Position Specific Information We are leveraging virtual technology to engage with you and keep us all safe while you explore a career with us. We will conduct all interviews virtually, to allow us to still connect about this job and proceed with our hiring process while practicing social distancing.
NxStage Medical, a Fresenius Company is on a mission to transform renal care. To do that, we continually seek the best-of-the-best to expand and improve our team of dedicated, innovative professionals.
PURPOSE AND SCOPE:
The Product Engineer is a seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. Acts as a subject matter expert to design and analyze mechanical systems, equipment and packaging. You will lead product and process development project activities related to NxStage Medical's disposable products.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- 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
- Author and execute product and system specifications, validation and test protocols and validation and test reports
- Lead Risk Management activities including, Fault Tree Analysis and Failure Mode and Effects Analysis activities to ensure design, use, and process shortcomings are identified and appropriately addressed
- Work with Quality Assurance and Research and Development to maintain an approved Quality System that complies with GMP's, QSR and ISO standards
- Domestic and international traveling (on an as needed basis, up to 20% of total time)
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Occasionally lift and/or move up to 50 pounds with assistance.
BS in Engineering with 8+ years of experience in medical device product design or manufacturing
MS or MBA preferred
Project Management Certification (PMP) desired
EXPERIENCE AND REQUIRED SKILLS:
Experience with ISO 13485 and/or related medical device standards
Experience with USP/EP/BP, ISO 13408, ISO 10993, ISO 14971 and ISO 11607 Aseptic Processing a plus
Familiarity with plastic fabrication methods such as injection molding, thermoforming, casting, extruding, solvent bonding, heat welding, ultrasonic welding
Strong understanding of product and process development of medical devices is required
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 entire development process, including specification, documentation and quality assurance
Experience working with contract manufacturers and/or suppliers, including outside the United States
Spanish fluency highly desirable
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.
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