The Senior Process Engineer will operate as a conduit between the manufacturing and product development teams, ensuring that activities needed to ensure a proper design transfer process have been completed successfully and according to Koru Medical’s standard operating procedures (SOPs).
What you will do:
- You will use process/manufacturing engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines, and product costs.
- Provide engineering support for new product and process introductions; ensuring that all activities are completed and documented in accordance with SOPs.
- Ensure quality of process and product as defined in the appropriate operation and product specifications.
- Assist in the selection of equipment based on analysis of specifications, reliability, and regulatory requirements.
- Support capital acquisition activity from specifying equipment, installation, and process validations.
- Analyze equipment to establish operating data, conduct Design of Experiments (DOEs) and result analysis. Lead and/or participate in process review meetings.
- Define manufacturing assembly and inspection tools/fixtures as needed to support product/process development activities.
- Lead in process failure mode and effect analysis (PFMEA), quality control plans, SOPs, and production part approval process (PPAP) generation associated with product transfers and launches.
- Complete process capability studies for in-process inspection(s) and generate subsequent inspection documentation.
- Conduct process validation, including review and approval of validation documentation, and MSA studies for new products/processes.
- Drive and execute effective communication with all stakeholders to enable project success.
- Work in a hands-on manner at the manufacturing site to support the implementation of new processes.
- Provide training for manufacturing team members.
What we are looking for:
- Bachelor’s degree in engineering, preferably Mechanical or Process Engineering - required
- 7+ years Medical Device Process / Manufacturing Engineering experience – required
- Writing and Executing Validations experience – required
- Ability to read and interpret complex engineering drawings and understand geometrical dimensioning & tolerancing – preferred
- Lean Six Sigma Green Belt Certification or above - preferred
This position requires you to be on-site daily. Remote work not permitted.
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore, employees assigned may be required to perform additional job tasks required by the manager.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
KORU Medical Systems provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, marital status, pregnancy, parental status, national origin, ethnic background, age, disability, political opinion, social status, veteran status, union membership or genetics.
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