Validation Engineer

4 weeks ago

Newburyport, United States UFP Technologies Full time
Job DescriptionJob Description

About UFP MedTech:

UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company’s single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants.

UFP Technologies, Inc. offers a competitive benefits package, including but not limited to:

  • Medical, Dental, Vision, Life, Disability Insurance
  • 401K with a matching contribution
  • Paid time off, Paid holidays, Employee discounts and much more

Location: This position will be on-site full-time in Newburyport, MA. The position holder will need to be within commuting distance (within 45 min).

Qualified applicants must be eligible to work in the United States to be considered for this opportunity. Employment based visa sponsorship (including H01B sponsorship) is not available for this position.

Validation Engineer Summary:

Responsible for leading validation efforts on new products and processes. This 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.

Validation Engineer 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 technical point-of-contact as needed; managing projects moving from development through transfer to production, i.e. validation.
  • Trains employees on process operating parameter/s 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.
  • Escalates problems as required and proposes solutions relative to meeting customer requirements, deliverables, and business profitability goals.
  • Perform all other duties as assigned or needed.
Validation Engineer Qualification Requirements:
  • Bachelor’s 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, 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.
  • Some travel

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