A Pelham manufacturer is seeking a Process Engineer to join the team at their newly expanded facility. In this role, you would work with the product development team to translate prototypes into production-ready, robust manufacturing processes for the company’s innovative products. This is a full-time, direct-hire opportunity with Fridays off!
Responsibilities of the Process Engineer
- 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, and identify critical process inputs to understand their impact on the manufacturing process outputs; identify and minimize output variation
- Assess technology and select new and innovative processes and equipment to expand manufacturing capabilities
- Lead 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 through MSA activity
- Execute various project activities in support of a defined Stage Gate process
- Present metrics and objective evidence to upper management to support product maturation through the Stage Gate development lifecycle
- Maintain proper documentation of technical and experimental activities within ISO 13845:2016, and maintain device history records within ISO 13485:2016
- Author and execute IQ/OQ/PQs and validation plans, overseeing the training, builds, and testing through report writing and approval
- Lead cross-functional team to develop PFMEAs to identify and mitigate risk, develop control plans, and understand the impact of validation activities and outcomes on process controls
- Transition new and revised processes into manufacturing
- Perform initial training and provide continued support as needed to ensure that operator proficiency is maintained
- Assess and track yield labor and material to identify variances and defects
- Summarize and compare performance to projected standards and cost models to ensure robust, profitable processes are transferred to manufacturing
- Maintain compliance with company policies, procedures, and quality management system
- Perform other duties as required or assigned
Qualifications of the Process Engineer
- Bachelor’s degree in plastics, a related engineering discipline, or the equivalent
- 4 to 6 years of experience in plastics manufacturing and/or the medical devices industry or equivalent
- Good computer skills (word processing, spreadsheets, Solidworks, Minitab)
- Proficient in design and process FMECA, Process Validation, and variability reduction applications
- Effective organizational, communication, and interpersonal skills
- Good visual acuity and fine motor skills
The Process Engineer works Monday through Thursday, 5:30am-4:00pm. Salary is commensurate with experience, starting at $80,000/year. Apply today to join this company’s talented, diverse workforce!
About Leddy Group
We are Leddy Group . . . a privately owned, regional staffing company serving NH, ME, VT & northern MA since 1994. We are one great brand with multiple specialties: accounting & finance, administrative & office support, engineering, human resources, industrial, skilled manufacturing, legal, and nonprofit.
At Leddy Group, we combine a consistency of values and traits with a singular standard for quality and best practices. We hold each other accountable to those standards, measure success by the quality of our outcomes, and establish goals based on continuous improvement metrics. We utilize a methodology and process to assess skills and experience; however, identifying the right “fit” is equally important for both candidates and clients alike. Our goal is to exceed your expectations. Our success is tied directly to your satisfaction.