Perform activities as they relate to Quality Systems and Regulatory Requirements such as: ISO 9001:2000; ISO 13485:2003; 21CFR Part 820; AS 9100.
Serve as a project Team Leader providing assigned customers with front line commercial and technical project engineering support including defining and documenting customer requirements, quoting, prioritizing workflow, and assisting in securing new business development opportunities.
Creates, manages, and maintains schedule, Risk Assessments and Communication Plans for all new product introduction activities at facility.
Provides production solutions that meet regulatory requirements, approach/exceed LEAN capability, and meet cost/delivery targets.
Serving as liaison between Engineering and Operations to review quotes, new business opportunities and to ensure the organization responds to issues in a timely manner.
Managing tool builds and supplying project timelines.
Troubleshoot existing issues from process control and tooling to inspection.
Follow all Vaupell policies and procedures.
Other duties as assigned
Job Qualifications/Requirements
Bachelor’s degree in engineering or related field from an accredited institution or equivalent experience or combination of education and experience.
Five (5) years in a Program Manager role.
Knowledge of SIM for medical validations.
In-depth understanding of part design, tool design, materials, processing, and fixtures.
Knowledge of tool design, hot runner manifolds, valve gate technologies, Mold Flow analysis.
Experience procuring and validating robotics and automation for part handling, assembly, decorating and packaging of medical device components and subassemblies. Following GAMP guidelines for automation validation.
Statistical analysis understanding of capability analysis, process centering with design of experiments and utilizing SPC and real time process controls on injection molded parts.
Design experience related to solid modeling of end of arm tooling or simple automation is desired.
PLC programming and controls engineering knowledge is a plus.
Competence in applying advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
Ability to read, speak, understand, and follow instructions in English.
Must be able to wear and properly use the required personal protective equipment.
Candidates must be a “US Person” (i.e., US Citizen or Permanent Resident) to ensure Vaupell's compliance with ITAR (International Traffic in Arms Regulations) and EAR (Export Administration Regulations)
Environmental Condition
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to fumes, airborne particles, and vibrations. The noise level in the work environment is usually moderate to occasionally loud. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Physical Requirements
Required physical skills and abilities (see below)
A = 20% or less of work time
B= 20 to 60% of work time
C = 60% or more of work time
Blank = Not applicable
Standing
B
Bending at waist
A
Walking
B
Reaching below shoulder level
A
Sitting
C
Reaching above shoulder level
A
Lifting under 25 lbs.
A
Grasping
B
Lifting 25 to 50 lbs.
A
Handling
B
Lifting over 50 lbs.
A
Finger Dexterity
C
Carrying under 25 lbs.
A
Feeling
B
Carrying 25 to 50 lbs.
A
Eye-Hand coordination
B
Carrying over 50 lbs.
A
Eye-Hand-Foot coordination
A
Pushing under 25 lbs.
A
Hearing, ordinary
C
Pushing 25 to 50 lbs.
A
Hearing, other (explain below)
Pushing over 50 lbs.
A
Seeing – near vision acuity
C
Climbing stairs
B
Seeing – far vision acuity
C
Climbing ladders
Depth perception
C
Balancing
Color perception
A
Kneeling
A
Keyboarding
C
Crawling
Pulling
A
Turning/twisting
A
Other
Vaupell reserves the right to change, modify or add to the Essential Duties and Responsibilities of any position at any time.
Vaupell is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, belief and spirituality, gender, age, sexual orientation, gender identity or expression, ethnicity/national origin, pregnancy, genetic information, veteran, or disability status.
