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 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-up 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
Manage medical device contract manufacturing projects from quoting through product release. Design, develop, and implement effective methods of manufacturing with focus to quality, throughput, repeatability, and operator safety.
Utilizing CAD, rapid prototyping and fabrication, design fixturing and tools to bring new and
improved methods of manufacture to new product development.
Communicate directly with customers to determine project goals, acceptance criteria, and set expectations
for new opportunities. Provide technical support and design assistance to customers as needed.
Perform process development and scale up activities in support of new product development
projects using the DMAIC and DFM methodology or equivalent.
Study, define, identify critical process inputs to understand their impact on the manufacturing process
outputs. Identify and minimize output variation. Utilize six sigma tools as needed.
Technology assessment and selection of new and innovative processes and equipment to expand manufacturing capabilities.
Investigate product quality issues through root cause analysis and implementation of corrective actions.
Develop inspection methods and tooling and challenge thru MSA activity.
Present 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.
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.
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, Mechanical Engineering, 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: Solidworks, Minitab, Microsoft Office, ERP software
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
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:
Mail: Pelham Plastics, Inc., PO Box 997, Pelham, NH 03076