ViantPosted 1 month ago

Engineering - Senior Process Engineer

ViantPosted 1 month ago

$31,200–$31,200 year

On-siteVega Baja, Vega Baja, Puerto Rico

Vega Baja, Vega Baja, Puerto RicoOn-siteFull Time$31,200–$31,200 yearSenior LevelLarge

Full TimeSenior LevelLarge

Job Summary

Develop new injection molding processes, assess existing workflows, and implement changes to improve product quality, productivity, and overall equipment efficiency. Provide technical leadership by mentoring process technicians, operators, and engineering personnel while troubleshooting production issues and collaborating with vendors to resolve machine and material problems. Monitor injection mold performance, generate internal quality documentation, and establish corrective action plans to ensure FDA, ISO, and safety compliance. Work independently on new process development and support ongoing manufacturing by identifying effective process control systems that meet customer cost, quality, and delivery expectations.

Required Qualifications

BS degree in Science or related discipline
5+ years' relevant experience
8+ years in medical device or equivalent
Demonstrated knowledge on tools/methodologies including SPC, DOE, GR&R, PMEA, process validation (IQ, OQ, PQ) and FDA, ISO/MDD standards
Experience leading projects, coaching, and mentoring for engineering and technical team personnel
Demonstrated interpersonal skills with ability to work within a team environment
Strong written/verbal communication skills
Training experience to FDA regulations or ISO standards
Must comply with requirements of ISO 13485
Must comply with company Environmental, Health and Safety standards
Must be able to work independently on new process development as well as troubleshooting current production issues
Must be able to start-up, operate and shut down process related equipment
Must be able to effectively lead and coach others
Must be able to demonstrate strong attention to detail
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