Essential Job Functions / Primary Responsibilities:
- Assist Engineering staff with all tasks related to process development.
- Perform material prep, set-up, and sampling of injection molds.
- Develop process windows for new molding and secondary operational processes.
- Take ownership of tool design criteria from a manufacturability standpoint all the way into production release.
- Perform OQ and PQ runs for molding and secondary operation processes.
- Develop and document standard operating procedures (SOP) and process-specific operating procedures (PSOP) using MS tools.
- Perform part measurements using standard metrology tools.
- Train manufacturing personnel on SOPs and PSOPs.
- Use standard problem solving tools, e.g., 8D, 5Whys, Fishbone.
- Conduct effective inter-departmental communication and escalation of issues.
- Follow ISO 13485 and 21 CFR part 11 and part 820 and Sil-Pro Quality System protocols.
- Work safely and act in accordance with all safety policies and procedures.
Other Responsibilities:
- Complete other projects and/or task as assigned to support business needs.
Education:
Required
- High School Diploma or equivalent
Desired
- 2 year technical degree
Experience:
Required
- 1-4 years
Desired
- 5+ years, including experience with clean room medical device manufacturing
Other Expectations, Skills and Abilities:
- Required
- Ability to challenge oneself to display consistent output by meeting all goals and deadlines
- Willingness to strive for excellence by producing work that is free of errors and mistakes
- Ability to demonstrate adequate job knowledge to deliver a world class performance
- Commitment to making improvements company-wide
- Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
- Commitment to be present for all assigned shifts
- Proven mechanical ability
Physical Requirements:
While performing the duties of this job, employees are regularly required to sit, walk and stand; talk and hear, both in person and by telephone; use hands repetitively to finger, handle, feel or operate standard office equipment; reach with hands and arms; and lift up to 25 pounds.
This job description and related documents are intended to describe the general nature and level of work to be performed.
This is not an exhaustive list of all duties and responsibilities. Management reserves the right to amend and change the job description as necessary to meet business and organizational needs.
Salary: $21.00