About UFP MedTech:
UFP MedTech, a division of UFP Technologies, Inc. (Nasdaq:UFPT), offers a full suite of design, development, process, and manufacturing services for single-use and single patient medical devices. We create OEM devices, subassemblies, components and packaging, from Innovation to Manufacturing, using a differentiated flexible materials portfolio with best-in-class operational excellence systems to improve patient outcomes for our clients.
Our culture is centered around innovation, collaboration, creativity, and service. This is the connective tissue that drives our pursuit of industry leadership and customer partnerships throughout our organization.
Position Location: Chicopee, MA
Summary: The Validation Engineer is responsible for leading validation efforts on new products and processes. The position works independently with medical customers, or on cross-functional teams to develop and execute validation protocols. Working with project engineers, program managers, quality and production personnel to create processes capable of meeting customer specifications, as well as, achieving target production rates and material yields.
Essential Duties and Responsibilities:
- Interfaces with medical customers, under the guidance of program management and design engineers to develop quality requirements and validation protocols (IQ, OQ, PQ, PPAP).
- Conducts statistical analysis in support of process validations.
- Provides hands-on design support utilizing design tools like: SolidWorks, CAD, and statistical tools to develop new products to meet customer requirements.
- Serves as a technical point-of-contact as needed; dealing directly with the customer to define the problem they are trying to solve, developing product specifications and managing development through the rapid prototype, design approval and transfer of products into production.
- Trains employees on process operating parameter to produce good product.
- Works on individual assignments and on cross-functional teams to develop, improve and launch medical products and manufacturing processes.
- Writes work instructions and inspection documentation.
- Writes clear technical reports around existing and newly developed processes.
- Trains operators and quality personnel on work instructions and inspection procedures.
- Manages projects as required, to meet or exceed project timelines within budget.
- BS degree in Engineering or technical field (e.g., polymer science, material science, chemistry) with 3-5 years relevant experience in a medical packaging, medical supply chain, and/or medical device design environment.
- Minimum of three years’ experience working on product validation.
- Strong background in statistics, well versed in Minitab SixPack supporting process validations.
- Knowledge of change control and change control management.
- Knowledge of thermoplastics, foamed plastics, and other materials and associated manufacturing processes utilized in medical packaging applications.
- Understanding of sterilization requirements for medical packaging applications.
- Solid project management skills, including managing multiple projects simultaneously, critical path identification, and new product introduction (NPI) processes.
- Familiarity with medical device qualification requirements and quality management system ISO 13485, ISO13485, ISO 17664 and 21 CFR 820 regulations.
- Hands-on experience interfacing with medical customers to develop quality requirements and validation protocols (IQ, OQ, PQ, PPAP).
- Experience writing work instructions (including single page visual WI and video) and inspection documentation, both incoming and in-process.
- Able to teach operators and quality personnel on work instructions and inspection procedures.
- Solid experience in writing clear technical reports around existing and newly developed processes.
- Project management experience, capable of meeting or exceeding project timelines.
- Strong aptitude for manufacturing processes, able to communicate on the manufacturing floor.
- Comfortable escalating problems and proposing solutions relative to meeting customer requirements, deliverable and business profitability goals.
UFP Technologies, Inc. offers a full benefits package, including but not limited to medical, dental, vision, life, disability, 401K with a matching contribution, paid time off, paid holidays, employee discounts and much more!
Please apply here.
UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer Minorities/Women/Veterans/Disabled.