Bihler of America
Bihler of America 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:
BihlerMed is looking for a Junior Mechanical Engineer, for a medical manufacturing company to execute research, development and production duties on new projects and existing production tasks.
Responsibilities & Duties:
- Ability to read and interpret blueprints, schematics and engineering drawings
- Support day to day production tasks
- Support Lead engineer on research and development tasks associated with bringing new products online
- Design fixturing as needed
- Support Engineering and development of new parts in preparation for production
- Support validation and documentation requirements as needed
- Adherence to FDA 21 CFR 820, 510(k), ISO 13485, ISO 14971, and international medical device regulations (MDD, CMDCAS) will be part of the requirements
- Ensures compliance to QSR and GMP and in all assigned areas
- Works closely with internal departments (Design, Planning, Production, Quality) to resolve in-house and supplier quality issues
- Periodically reviews the functional status of equipment in the department and works with engineering and maintenance to repair, upgrade or replace equipment as required. Recommends technology and equipment upgrades.
- Maintains working knowledge of SPC and data analysis
- Possesses competent technical writing skills
- Works in a hands-on environment
- Follows company policies and maintains confidentiality of the company
- Perform all other duties, as assigned
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
- Mechanical ability
- Commitment to quality & professionalism
- Ability to multitask
- Must be a cooperative team member
- Will receive training and given the opportunity for growth
- Positive attitude and a team player
Physical Requirements:
- Be able to work in a manufacturing environment
- Working at a computer for normal periods
- Frequent standing, lifting, and walking
Specific Knowledge, Licenses, Certifications, Etc.:
- Bachelor’s degree in engineering or related field of study
- Equivalent work experience in an ISO/Medical Device related background a plus, SolidWorks preferred.