BihlerMed
BihlerMed is an Equal Opportunity Employer (E.O.E). We require new hire Drug and Alcohol testing as well as pre-employment and background checks.
Description:
This full-time position is responsible for research, development and production duties on new projects and existing production tasks.
Responsibilities & Duties:
- Works well with others
- Works in a hands-on environment
- Possesses competent technical writing skills
- Support validation and documentation requirements as needed
- Work in the toolroom occasionally
- Support Lead engineer on research and development tasks as well as day to day production
- Works closely with internal departments (Design, Planning, Production, Quality)
- Maintains working knowledge of statistics and data analysis
- Knowledge of or willingness to be trained in national, and international medical device regulations such as FDA 21 CFR 820, 510(k), ISO 13485, ISO 14971, MDD, and CMDCAS
- Follows company policies and maintains confidentiality of the company
Skills & Requirements:
- Computer skills (Microsoft, Excel, Word, etc.)
- Math skills (Statistics/Statistical Rationale, Sampling preferred)
- Verification and Validation a plus
- Proficiency in communicating (verbal and written) in English
- CAD experience, SolidWorks preferred
- Mechanical ability
- Equivalent work experience in an ISO/Medical Device related background a plus
- Ability to use measuring equipment (micrometer, comparator, etc.), fixtures, tooling, and toolroom equipment
Specific Knowledge, Licenses, Certifications, Etc.:
- Bachelor’s degree in engineering or related field of study
Physical Requirements:
- Be able to perform work in assembly plants
- Frequent standing, lifting, and walking
