Sr. New Products Development Project Engineer

PROMED MOLDED PRODUCTS INC•Plymouth, MN

About The Position

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best. ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world. Working as one to help many. POSITION SUMMARY From a strategic perspective this position will take the lead project management role as assigned for new projects, new technology opportunities and capital or equipment expansions. From a tactical perspective this position will assist manufacturing with existing products and processes with the objective to improve performance measures that include product quality, on-time delivery and manufacturing costs. The Senior New Product Development Project Engineer works under limited supervision from management. The Senior New Product Development Project Engineer ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

Requirements

Bachelor’s Degree in engineering
Medical device-related background
Minimum of ten years of experience in the field
Experience with MS Office
Problem-solving and critical thinking skills
Strong interpersonal, written, and verbal communication skills
Clearly conveys ideas and receives information effectively
Self-starter with a proven ability to successfully work with minimal supervision
Professional, courteous, and friendly personality

Nice To Haves

Masters degree in engineering or business administration
Knowledge/Training to ISO 13485 (current), Medical Devices QM System
Knowledge/Training to ISO 14971 (current), Risk Management
Knowledge/Training to QSR 21 CFR 820, 210 and 211, GMP Regulations for Pharma and medical device industry
Experience with hands-on technical work
Demonstrated interest in the medical device and pharmaceutical industry
Working knowledge of English (verbal and written)

Responsibilities

Project management for a variety of projects including new technology, capital equipment purchases, and new product development.
Project planning.
Project status.
Project execution.
Customer communication.
Assist in the quoting process for new customer projects.
Assist in manufacturing with existing products and processes.
Analyze statistical data and product specifications to improve manufacturing processes.
Investigate root cause and implement corrective action as it pertains to customer complaints and/or internal non-conformance action.
Identify and/or resolve dimensional characterization methodology and inspection criteria.
Assist in the mentoring process for other engineering and manufacturing people at ProMed.
Identifies and implements a comprehensive education plan to continually advance technical skills and personal development as well as enhancing organizational effectiveness.
Participates in project planning.
Establishes and cultivates a network of support (laboratory, quality, manufacturing, engineering, sales, and marketing) to facilitate completion of assignments.
The employee is expected to develop acceptable work habits, skills, knowledge, and contributions consistent with the Engineering I position level.
This job also requires performing other duties as assigned.