Overview:

The Senior/ Principal Process Engineer will be responsible for developing, implementing, optimizing, testing, and validating processes for medical device products for R&D designs, within a low volume manufacturing line and to commercial release at high volumes.

Educational Requirements:

BS in Mechanical Engineering, Industrial Engineering, Materials Engineering, Manufacturing, or equivalent technical field, and 5+ years of hands-on industry experience.

Skills/Experience

• Participates in the creation and review of product process development objectives

• Develop, implement, & optimize improved engineering and manufacturing processes

• Identifies and develops technical specifications, drawings, and process specifications

• Performs design reviews and pre-validation assessments to identify processes to improve

• Troubleshoots and improves production when failures occur and/or yields fall below targets

• Participates in review of equipment, fixtures, and tooling; and implement improvements

• Own processes that may include lapping, milling, dicing, and bonding

• Write and review process instructions and train support staff

• Investigates non-conforming material and recommends corrective action plans for discrepancies

• Lead process validation activities (DOE, Gage R&R, IQ, OQ and PQ) in cooperation with quality engineering

• Participates in pFMEA’s, process validations, and verifications.

• Utilize accurate metrology and statistical methods for process improvements; experience with Geometric Dimensioning & Tolerancing (GD&T)

• Experience with design for manufacturability, tolerance analysis, cost analysis and working with engineering drawings meeting quality standards

• MS degree a plus

• Experience with medical devices a plus

• Experience with piezoelectric devices a plus

• Semiconductor processing experience a plus