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: Senior Project Engineer
Reports to: Engineering Manager
Work with the Pelham’s customers, product development team and operations 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, develop processes, procedures, workflow 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.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
Reviews product development requirements and integrates new and existing equipment and process capabilities to meet customer’s target specifications, budget and delivery schedule.
Works with Sales, Engineering and Operations to transfer successfully quoted projects through the development process (SOP-012). Responsible for the managing and executing the development activities in the design and introduction of development programs and is a key resource for technical expertise and knowledge.
Lead project meetings providing project status, updating technical actions, risks and delivery schedule.
Using 6 Sigma tools, study, define, identify critical process inputs to understand their impact on the manufacturing process outputs. Identify and minimize output variation.
Initiates new or revised engineering documentation, including those of highest complexity such as the Standard Operating Procedure (SOP) and tracks through appropriate approval cycles and implements.
Defines and communicates customer validation requirements. Generates validation protocols (IQ/OQ & PQ) and ensures their preparation, execution and closes final reports. Develops and utilizes tools, such as process flow charts, design of experiment (DOE), process failure mode effects analysis (PFMEA), control plans and master V&V plans to meet customer validation requirements.
Transitions new and revised processes into manufacturing and performs initial training. Leads IQ/OQ and PQ activity Creates set up specifications, performs initial training and resolves related issues to ensure a smooth transition. Provides continued support for training as needed to ensure operator proficiency is maintained.
Assesses and specifies off the shelf components, resins, extrusions, material selection and equipment. Will create initial specifications.
Defines build and test plans, coordinates the scheduling of personnel and equipment with Operations.
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.
Responds to external technical issues, including but not limited to Supplier Corrective Action Request (SCAR) and Corrective Action and Preventative Action (CAPA).
Provides guidance to lower-level engineers and may assign tasks and deadlines as required.
Maintains compliance to the Pelham Plastics Quality Management System procedures. Adheres to the company’s policies & procedures.
EDUCATION: Bachelor’s degree in Plastics or a related engineering discipline or the equivalent
EXPERIENCE: 5 to 8 years experience in a plastics manufacturing environment and/or medical devices industry or the equivalent.
SPECIAL SKILLS: Understanding of plastics engineering principles, theories, concepts, practices and techniques; able to read blueprints and schematics; use of statistics; PC proficiency; analytical and problem-solving capabilities; presentation skills, project management skills, effective mentoring, 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:
- Website: email@example.com
- Mail: Pelham Plastics, Inc., PO Box 997, Pelham, NH 03076
- Fax: 603-886-3311