**Position can be based in Ogden, Utah or Waltham, MA**
PURPOSE AND SCOPE:
The Sr. Engineer possesses specific product lines knowledge to be a resource and key technical expert to support related projects. The Sr. Engineer is largely unsupervised and self-motivated to lead projects. Shall be capable of being given high level tasks and working independently to organize work, from required Cross Functional Teams (CFT) and to produce the final product or outcome assigned. The Sr. Engineer is expected to be trusted to provide production support to ensure product reliability, dependability and efficient manufacturability. The Sr. Engineer is also capable of formulating new research projects - from starting with a concept, formulating a pre-development plan and completing a feasibility study. The Sr. Engineer can act as the expert in a cross technical team (CTT) to execute a project and/or solve hard to diagnose problems. The Sr. Engineer, as a technical expert, may be called upon to provide system related technical seminars across the company.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Applies the education and experience to develop, maintain and resolve any issues with assigned systems of responsibility.
Subject matter expert role at all stages from converting lab scale technology into a commercial medical product to supporting the released product.
Is familiar with and follows FDA/ISO Design Control principles and regulations in product development.
Designs and develops products that meet User inputs and supports business and marketing strategies to further generate revenue growth.
Applies Risk based procedures throughout the product development process and the product life cycle.
Authors testing plans, engineering test reports, and position and/or white papers using good documentation practices
Encouraged to generate of idea for potential inventions.
Act as a Project Leader for major projects assigned (concept through release).
Participate as a CFT or CTT member as assigned.
Develops and establishes detailed Design (engineering) input specifications to ensure product function, minimized patient risk and cost effective manufacturing.
Develops and gives presentations dealing with projects, proposals, designs and project status updates.
Assist in development of custom equipment to support small-scale product assembly and testing.
Assist in producing manufacturing procedures.
Prepare and deliver assigned presentations.
Executes projects with clear objectives and timely deliverables. Understand the goals and contents of development and research projects.
Foster culture of collaboration with CFT members, CTT members and inner/inter departmental personnel.
Interfaces regularly with vendors/consultants based on responsibilities and assignments.
Provide assistance to manufacturing in establishing product fabrication facilities and procedures as part of Design Transfer. Maintain observation of production statistics to ensure production equipment and processes are effective. Provides technical support to other departments as assigned.
Maintain clean workspaces.
Provide mentoring and assistance to Engineer II and I level staff.
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Works under Minimal supervision and may be asked to contribute to performance evaluations of other employees.
Other duties as assigned.
Specific Biocompatibility Duties:
Define biocompatibility requirements for medical device and pharmaceutical products
Determine testing and evaluation strategies to assess potential biological safety risks for materials contact with the human body
Design chemistry studies to characterize extractable/leachable chemicals from Fresenius’ products.
Support toxicological risk assessments of extractable/leachable chemicals, and derivation of allowable limits
Interface with cross-functional teams for product development, and support project execution and prioritization
Partner with internal and external laboratories for new test method development
Manage contract laboratory relationships, including cost and quality improvements
Participate in development of international standards for biological safety evaluation of medical devices
Propagate culture of rigorous science and drive process improvement for biocompatibility group
Provide technical leadership and support for issue resolution within biocompatibility group and cross-functional teams
Provide assistance to other staff with complex evaluations that require considerable judgment and initiative
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
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.
Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
5 - 8 years' related experience;
Master's degree with >3 years' related experience;
PhD without experience; or equivalent directly related work experience.
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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