Perma Pure, a well-respected manufacturer of high-performance moisture management products for the medical, scientific analysis and environmental monitoring markets, has an immediate need for an outstanding Manufacturing Engineer to continue our strong record of growth. This is an excellent opportunity for an individual who thrives on the challenge of manufacturing high-value products for demanding customers in a continuous-improvement environment. Our products are used in critical applications such as patient monitoring in hospital operating rooms and air quality control equipment in industrial plants and have been to locations as remote as Mount Everest and in orbit around the earth.
Essential Job Functions:
The Manufacturing Engineer is responsible for the effective application of Validation Protocol and Report creation, Equipment and Process Validations (IQ, OQ, PQ, and PV), Process FMEA's, SPC, Process Control Plans, Process Automation, Sampling methodologies, and Data Analysis.
- Manage the injection molding process, tooling, extrusion process, and equipment in the plant.
- Knows and uses the fundamental concepts, practices and procedures of Statistical Process Control (SPC).
- Prepares Validation protocols, manages studies, evaluate test results and publish final Validation Reports.
- Interfaces with customers on process changes and validations.
- Supports customer inquiries.
- Supports in evaluating returned products and reported complaints for failure mode using root cause analysis techniques.
- Works with Design Team to assure ability to manufacture new designs and lead design transfer to production activities.
- Supports the development and maintenance of Process Failure Mode Effects Analysis (PFMEA) for each product line.
- Statistically analyzes data (Preventive Maintenance, First Pass Yield, and Calibration) and presents metrics at Management Review Meetings
- Supports management in the development, planning and execution of a lean enterprise transformation strategy and metrics.
- Takes responsibility for planning and assisting in the execution of various Lean transformation events targeted towards improving the business's overall performance.
- Overseas operations to ensure that waste and production costs are minimized and there is conformance to safety standards and quality procedures.
- Mentors and motivates processing personnel, providing training and development to optimize their performance and long-term value to the company.
- Establishes and communicates performance standards to production personnel, recognizing and rewarding individual and team accomplishments and counseling performance deficiencies.
- Directs requisitions for maintenance and repair of production equipment, and for machine parts and manufacturing supplies.
- Develops, maintains and reports production-related information regarding yields, efficiencies and labor utilization to management.
- The position includes all other responsibilities that may be necessary to fulfill the duties associated with the position or as may be assigned.
Qualifications:
The successful candidate will be one who can demonstrate that they have the skill to establish credibility with others.
- Engineering degree REQUIRED, preferable Mechanical, or Chemical Engineering
- 2+ years manufacturing engineering experience in a medical device, pharmaceutical or chemical manufacturing organization, preferably using computerized manufacturing equipment minimum
- 2+ year experience in plastics injection molding, understanding of injection molding machines REQUIRED
- 2+ year experience in plastics extrusion preferred
- Working knowledge of FDA regulations, Good Manufacturing Practices (GMPs) and ISO standards - experience with ISO 13485 preferred, not required
- Demonstrated understanding of production scheduling and other production variables such as run-rates, processing times, change-over times, etc.
- Demonstrated knowledge of efficient and safe manufacturing operations to include product and associate safety, OSHA standards, product quality (success rates), throughput delivery and cost control (minimizing downtime and waste, optimizing yield)
- Experience with statistical software (e.g. Minitab) using statistical methods such as ANOVA, hypothesis testing, capability analysis preferred.
- Proficient using Microsoft Office software: Outlook, Word & Excel is required
- Absolute personal integrity and credibility
- Excellent people skills with personnel at diverse positions within and outside of the organization are essential - at all levels
- Values ideas of others and has experience working in a team environment
- Ability to lead / manage multiple projects concurrently
- Verifiable track record of delivering results
- Results oriented and self-starter
- Demonstrated ability to analyze and resolve problems.