We're Hiring - Mechanical Engineer based in our Cincinnati HQ
TyTek Group is a family owned and operated company entering a new phase of growth and we are expanding our Engineering Department.
Day-to-day completion of engineering duties and support of clients. Generate documentation and systems for compliance with FDA Medical Device Regulations (including the current Good Manufacturing Practice (cGMP)), ISO 13485, European regulatory requirements (Medical Device Directive (MDD)), etc. Responsible for the creation of all materials required for the supply factory to manufacture the product according to both customers print and satisfaction including but not limited to CAD files and technical specifications.
Essential Duties & Responsibilities include the following:
- Evaluate and recommend sources for production to include product, required tooling and/or secondary operation services and continually liaise with them to assure good, consistent quality production.
- Compliance with standards and regulations established by the Company or relevant regulatory bodies.
- Responsible for the maintenance of all device master records and technical files to comply with applicable regulatory and ISO requirements.
- Record, investigate, analyze, determine corrections, corrective action and preventive action and trend customer complaints and non-conformances.
- Assist in analyzing and evaluating information concerning manufacturing problems corrective actions and preventive actions, quality system concerns, etc. for review by appropriate management personnel.
- Assist manufacturing and planning in inspection and testing activities to ensure continuous control over materials, facilities, and products.
- Assist and/or perform training activities related to quality system and product quality.
- Other duties may be assigned, as necessary.
Education & Experience:
Minimum Bachelors Degree in an Engineering discipline, Mechanical preferred, with minimum 10 years experience. Minimum 8 years working in a company with quality systems within an ISO environment.
- Ability to read and to interpret technical drawings, either hard copy or electronic in commonly used electronic engineering formats and interface with customers similar programs is absolutely essential.
- Ability to create a technical drawing electronically and all necessary data that can be used for the production facility to manufacture the product is essential.
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Knowledge of a foreign language would be beneficial.
- Ability to work with minimal direction / supervision a must.
- Ability to prioritize.
FDA current Good Manufacturing Practice (cGMP), ISO 9001 and/or ISO 13485; Medical Device Directive (MDD); SolidWorks; PMP / CSSGB / CSSBB certification preferred.
Yes, this position requires on average 25% travel both domestic and international (largely overseas).
Available for the right candidate.
Benefits & EEOC Statement:
TyTek offers a great work environment, professional development, challenging careers, and competitive compensation and benefits packages including paid time-off, sick leave, health insurance, and 401k.
TyTek is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Submit a current resume and cover letter to firstname.lastname@example.org.