Pelham Plastics is dedicated to hiring talented people who bring diverse and new work experience, skills and perspectives. This is the foundation to our team success. We offer an attractive work schedule of 4 day/10 hour work week and opportunity to work on projects, products and processes that result in life saving devices. If we do not have a job posted at this time or in your particular area of interest, we encourage you to apply anytime.
Job Title: Process Engineer II
Reports to: Engineering Program Manager
Work with the product development team to translate prototype medical devices and components into production ready, robust manufacturing processes for new disposable medical products. This position applies technical knowledge to innovate, design and develop processes procedures and tooling for scale-ups into commercialization. Responsible for identifying and process ranging of critical process inputs and the execution of IQ, OQ and PQ. Support customer and company value through process and design for manufacturability.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
- Perform process development and scale up activities in support of new product development projects using the DMAIC and DFM methodology or equivalent.
- Using 6 Sigma tools, study, define, identify critical process inputs to understand their impact on the manufacturing process outputs. Identify and minimize output variation.
- Technology assessment and selection of new and innovative processes and equipment to expand manufacturing capabilities.
- Leads scale-up to test for manufacturing and quality issues
- During development phase, investigate product quality issues through root cause analysis and implementation of corrective actions
- Develop inspection methods and tooling and challenge thru MSA activity
- Execute various project activities in support of a defined Stage Gate process. Presents metrics and objective evidence to upper management to support product maturation through the Stage Gate development life cycle.
- Maintain proper documentation of technical and experimental activities within ISO 13845:2016. Maintain device history records within ISO 13485:2016.
- Development of manufacturing documentation
- Author and execute IQ/OQ/PQ’s and validation plans overseeing the training, builds and testing thru report writing and approval. Lead cross functional team to develop PFMEA’s to identify and mitigate risk. Lead team to develop control plans and understand the impact of validation activities and outcomes on process controls.
- Transitions new and revised processes into manufacturing and performs initial training. Provides continued support for training, as needed, to ensure that operator proficiency is maintained.
- Assesses and tracks yield labor and material to identify variances and defects. Summarizes and compares performance to projected standards and cost models to ensure robust, profitable processes are transferred to MFG
- Maintains compliance to the Pelham Plastics Quality Management System procedures. Adheres to the company’s policies & procedures.
- Performs all other duties as required or assigned
EDUCATION: Bachelor’s degree in Plastics or a related engineering discipline or the equivalent
EXPERIENCE: 4 to 6 years experience in plastics manufacturing and/or the medical devices industry or the equivalent.
SPECIAL SKILLS: Computer literate; word processing, spreadsheets, Solidworks, Minitab
Proficient in design and process FMECA, Process Validation and variability reduction applications; effective organizational, communication and interpersonal skills.
PHYSICAL REQUIREMENTS: Able to lift up to 20 lbs; sit, stand, bend and stoop; good visual acuity and capable of fine motor skills.
Job Title: Assembler (2nd Shift – Part and Full Time)
Reports to: Production Supervisor
We are looking for an Assembler to join our second shift team. We are willing to train the right candidate who meets these requirements:
- Steady work history
- Ability to understand spoken and written instructions in English
- Basic computer skills needed
- Ability to sit or stand for prolonged periods of time
- Enjoy working in a fast-paced team environment
- Good visual capability for inspection, occasionally with magnified ring light
- Manual dexterity to work with small parts in a clean room environment.
Under direct supervision, performs rudimentary assembly operations of a repetitive nature to assemble routine plastic components for the medical device industry.
PRINCIPLE DUTIES AND RESPONSIBILITIES
- Performs rudimentary assembly of plastic medical components in accordance with written and verbal work instructions (WI’s), manufacturing procedures (MP’s) and drawings / blueprints.
- Performs in-process inspection of components for defect awareness.
- Uses fixtures and dies, such as cut to length fixtures, to modify plastic components.
- Performs routine tasks in preparation of assembly such as cutting tubing to specified length and cleaning components.
- Operates routine equipment within the assembly process such as but not limited to, eye coring machine, hot blocks, RF machine, and pad printer to alter parts and tubing configurations.
- Uses measurement devices such as vernier calipers, micrometers and scales in performing routine assembly of plastic components.
- Data entry of component quantities, scrap quantities and defect codes, and other required information into the company’s ERP system with the use of a computer, keyboard, mouse and barcode scanner.
- Adheres to good documentation practices and completes manufacturing documentation as required (i.e., job travelers, run sheets, hourly data, communication board, etc.).
- Maintains work area by making sure work station is in clean and orderly condition and meets the company’s standards for cleanliness, safety and line clearance.
- Maintains compliance to the Company’s Quality Management System procedures and guidelines.
- Notifies the Group Leader or Supervisor when components do not conform to specification.
- Reports any safety related issues to Group Leader or Supervisor.
- Performs other duties as assigned which may include; cleaning, vacuuming and trash disposal.
EDUCATION: High School diploma or equivalent. Ability to read, write and comprehend the English language. Must follow good documentation and manufacturing practices. Ability to follow written and verbal work instructions. Basic computer skills (keyboard and mouse) are required.
EXPERIENCE: 0 – 2 years related experience assembling small parts. Ability to learn to read drawings / blueprints.
SPECIAL SKILLS: Fine motor skills, good mechanical aptitude, ability to learn to use microscope and or magnified ring light. Ability to learn to use measurement devices (Vernier calipers, micrometers, pin gauges, etc.). Ability to work with others in a team environment. Handle and work with sharp objects such as razor blades, cutters and x-acto knives.
PHYSICAL REQUIREMENTS: Ability to push, pull or lift up to 20 lbs; position self to sit, stand, bend and/or stoop for long periods of time without being able to leave the work area; good visual acuity with or without corrective lenses; fine motor skills; and able to work in an environment that requires wearing frocks, shoe covers, hair/beard covers, gloves, hearing protection and safety glasses.
If you are an individual who cares about making quality products that save lives, consider joining our team. You will enjoy great benefits, a supportive team, and a 4-day work week.
Resumes may be submitted via:
- Website: firstname.lastname@example.org
- Mail: Pelham Plastics, Inc., 42 Dick Tracy Drive, PO Box 997, Pelham, NH 03076
- Fax: 603-886-3311