Assoc. R-D Engineer
As a R-D Engineer I you will focus on delivering R&D to new therapies, while adhering to policies using specialized knowledge and skills. The role requires effective management and prioritization of multiple concurrent tasks in an ambiguous environment. Responsibilities may include the following and other duties may be assigned:
Develop and coordinate small projects, as asked by the project team, with supervision from higher level engineering;
Assist in developing customer and product specifications;
Develop, troubleshoot, qualify, and/or validate fixtures, equipment, and test methods utilized to evaluate product design;
Assist in preparing engineering drawings with specifications and tolerances;
Create test plans/protocols, perform testing, and analyze and document results;
Process engineering change orders;
Assist in developing Failure Modes, Effects, and Criticality Analyses;
Present technical findings or task status to cross functional teams through meeting minutes, presentations, design reviews and other means of communication;
Perform job functions in accordance with applicable GMP and ISO standards;
Maintain required documentation per GDP procedures.
Must Have – Minimum Qualifications
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.
Nice to Have
Degree related to Biomedical Engineering, Mechanical Engineering, or Materials Science & Engineering;
Minimum 1 year experience in medical device industry with Class II or III product systems, preferably with vascular therapies, products and technologies (e.g. catheters, liquid embolics);
Experience with fixture, equipment, and test method development, especially for in-vitro clinical simulation testing of device performance (e.g. bench-top model).
Ability to compile, organize, and communicate technical data using Excel, Word, Visio, and PowerPoint;
Experience using common engineering software (e.g. CAD, Statistical – Minitab or JMP, MATLAB, PLM – Agile, Enovia or Windchill);
Experience using statistical techniques (e.g. DOE, Monte Carlo, ANOVA, Gage R&R, or Six Sigma tools and principles);
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS
Autonomy: Entrylevel individual contributor on a project or work team. Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A job at this level is focused on self development.
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a University Degree, 0 years of experience required.
