Packaging Engineer

Position: Packaging Engineer

Location: Mansfield, MA.

Duration: Long-Term Contract

Required Skills

• Med Device experience

• Must be familiar with EO sterilization interactions with Packaging

Job Description

Engineer III, Packaging, Product Development (Senior)

Responsibilities:

Reporting to the Manager of Packaging Engineering, this successful individual will take an individual contributor senior level role with packaging projects and possess the ability to influence with multi-functional, high performing teams in a fast-paced environment. This individual will be responsible for specifications, documentation, and package testing in support of New Production Introduction (NPI), Sustaining, and Continuous Improvement projects. In addition, this position is responsible for assisting with the operation of the on-site package testing laboratory including sample preparation, test execution and reporting.

Essential Functions Of The Position:

Team member of projects involving design and manufacturing resources, both internal and external. Specific expectations include:

Packaging Development

• Responsible for the planning, design, development, validation, and improvement of package systems for sterile and non-sterile medical devices with a focus towards innovation, sustainability and usability that align with team and company objectives.

• Responsible for ensuring medical device packaging meets or exceeds requirements for end user functionality, safety, manufacturability, regulatory, sustainability and business and program objectives.

• Establishes design requirements, performance, and business criteria through collaboration with health care providers, internal cross functional groups, program management and packaging team members.

• Work as the lead engineer by collaborating with R&D, Quality, Regulatory, Labeling, Operations, suppliers, and others, to design, develop, validate, and implement package systems from exploratory through product commercialization.

• Leads strategic initiatives within the packaging team with focus on best practices, stake holder value, quality, and cost effectiveness, standard work, and design and technical rigor

• Proven independent technical team member. This includes but is not limited to knowledge of project management skills, ability to coordinate with cross-functional teams, technical knowledge of various medical grade material and suppliers, use of design and manufacturing methodologies, risk analysis, testing method development, and package system validation.

Tooling and Equipment:

• Shall assist in developing packaging concepts using internal and external resources.

• Understanding of ergonomics as related to repetitive stress injuries.

• Define and track project tooling and equipment schedule and cost.

Verification and Validation:

• Experience in generating test plans, writing protocols, conducting design verification/validation, and processing validation for package testing is required.

• Executes package testing and maintains complete records of packaging process and equipment design activities, test data, and other pertinent information for each project.

• Able to define statistical sample sizes as related to variable and attribute data, based on established company and industry standards.

• Responsible for developing detailed process qualification strategies, Process Characterization, IQ, OQ, and PQ for packaging equipment.

• Analyze data, identify root causes, draw conclusions, and generate reports that encompass data driven conclusions.

Qualifications:

• A bachelor’s degree in Packaging Engineering or a related Science field, advanced degree is preferred.

• 5-7 years of experience, a M.S. degree with 3-5 years of experience; a Ph.D. with 2 years of experience or comparable in-depth knowledge of materials and processes used in construction and manufacturing of medical device packaging (thermoform tray, pouches, operation of sealing equipment, etc.) is required.

• Solid understanding of a broad spectrum of packaging materials, structures, components, and related conversion processes is required.

• Extensive knowledge of FDA, ISO, ASTM, and ISTA requirements related to packaging and labeling, and how to apply them is required. Standards include, at minimum, ISO 11607, ISO 13487, ISO 17025, FDA 21 CFR part 820.

• Generate detail specifications using GD&T methodologies

• Technical Leadership skills are required; Project Management skills are preferred

• Ability to prioritize multiple rapidly changing priorities with minimal direction is required

• Strong technical writing/documentation skills are preferred.

• High level of written and verbal communications skills

• Proficient is computer software programs such as SolidWorks, ArtisoCAD, and barcode generation software (Bartender, Loftware, Labelview, etc.).

• Proficient PC skills (MS Word, MS Excel, MS Project, MS Visio).