Orchid Orthopedic Solutions
Manufacturing Process Engineer
: Arcadia CA
SUMMARY OF POSITION
The Manufacturing Process Engineer coordinates and supports all aspects of Process Development, cost generation for RFQ's , and Process Improvement for Orchid Arcadia
Determines manufacturing processes required to produce customer parts to print and specifications
Estimates manufacturing costs of product per customer drawing and requirements, including cycle and set-up times, raw material and outside processes
Interfaces with customers, as required, to obtain all information necessary to complete the cost estimates
May generate BOM, routings and programs that tie to ERP processes
Ensures customer and quality standards are met
Ensures compliance with medical device regulations
Other duties as assigned by Supervisor or designate
Interface with Corporate Project Management to ensure all quotes are ready for review.
Provide engineering support to the manufacturing floor and resolve issues impacting production fulfillment (e.g. develop, troubleshoot and improve manufacturing processes, fixtures, tooling or equipment and resolving NCRs/ CAPAs).
Provide engineering support to outside suppliers, ensuring quality and production targets are met.
Train, develop, and/or provide work direction to operators, technicians and technicians
Write and perform IQ, OQ and PQ when introducing new or changing existing manufacturing equipment.
Lead efforts at updating PFMEAs. Be a key participant in the maintenance of BOM and Routings in the ERP system.
Maintains a safe and healthy work environment by following standards and procedures; complies with legal and ethical requirements.
Performs other related duties and tasks as required.
EDUCATION AND EXPERIENCE
B.S. in Mechanical or Biomedical Engineering, or comparable education AND
10 years of experience working with designing and quoting parts
SKILLS & ABILITIES REQUIRED
Good written and oral English communication skills.
Advanced skills in MS Office Programs, SolidWorks or similar CAD/CAM programs, Minitab
Ability to read, analyze, interpret and generate engineering drawings utilizing geometric dimensioning and tolerancing (GD&T).
Working understanding of quality statistical models and metrics (confidence/reliability intervals, DOE, regression/trending, SPC, t-Tests, acceptance plans).
Very familiar with manufacturing processes such as various machining processes, inspection techniques, and ultrasonic cleaning.
Skilled with mechanical equipment and gauges such as microscopes, CNC machines, Instron, calipers and other measurement gauges.
Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003
Must be able to work in a fast-paced quality-oriented manufacturing environment.
Must demonstrate an ability to independently manage, prioritize, problem-solve, and be successful in dealing with staff at all levels of the organization.
From our employees, to our customers, to the surgeons performing surgery and ultimately, to the patients that receive care using the products we make, we strive to affect people’s lives in a positive manner. We feel fortunate to be working in an industry that has the ability to impact lives in such a profound way and we are proud of the services we provide.