Sr. New Products Development Project Engineer at PROMED MOLDED PRODUCTS INC – Plymouth, Minnesota

• 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.

• 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

• 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)

• Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
• Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
• The noise level in the work environment is usually minor;
• Duties are performed indoors;
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
• Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
• The position requires the individual to meet multiple demands from several people and interact with internal and external people;
• Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
• Employee may have duties involving walking on even or uneven surfaces;
• Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
• Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
• It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently.
• Employee must see and hear on a continuous basis as well as speak frequently;
• Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.

ProMed offers a generous benefits package including:

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.