Mid-Level Packaging Engineer
Company: Katalyst Healthcares & Life Sciences
Location: North Haven
Posted on: May 28, 2023
Job Description:
Responsibilities:
- The Mid-Level Packaging Engineer is a key operation
representative within the North Haven site and supports both the
AST (Advanced Surgical Technologies) and GSP (General Surgical
Procedures) Focus Factories.
- The Packaging Engineer will be responsible for completing tasks
which support the day-to-day operations and strategic projects to
the business.
- General responsibilities include packaging/manufacturing
process evaluation, troubleshooting and support of in-house
packaging/labeling/sealing equipment of products and
processes.
- Conduct engineering studies and analyzing results to support
process validation.
- Provide engineering support for production packaging/assembly
equipment, methods and process validation of new and existing
products.
- Collaborate on project teams to develop high quality, high
reliability and highly manufacturable packaging for medical devices
at Healthcare.
- Work under the direction of Principal Level Engineer in a
fast-paced environment supporting program initiatives and compliant
with company best practices.
- Contribute to continuous improvements in overall product cost
and quality.
- Participate in DFM / DFA activities assuring that
packaging/production processes and equipment are taken into
consideration.
- Maintain documentation associated with packaging/manufacturing
processes.
- Provide technical support for production packaging/labeling
tools and software including assembly/sealing equipment and
automation.
- Follow established guidelines and management direction with
regard to engineering decisions.
- Advise leadership of developments which may affect schedule and
costs.
- Participate on projects to concurrently develop packaging
assembly methods, tooling, equipment and processes for new and
existing products.
- Partner with Manufacturing to develop lean principals to
implement solutions for product packaging, labeling and
sealing/assembly.
- Create standardized work and process maps that result in an
optimized production system and extended value stream.
- Conduct, coordinate and aid in formal Process Validations
including protocol development and execution.
- Support project team members in achieving business objects
related attainment of Safety, Quality, Service, and Project
Schedule and Cost goals.
- Follow established procedures to perform detailed, accurate,
and compliant engineering documentation for Master Validation
Plans, PFMEA, Equipment Installation, Characterization,
Qualification and Validation activities.
- Interactions with manufacturing providing hands-on support and
responsibility for metrics such as labor time, lead-time,
capability, and yield.
- Provide detailed engineering analysis and documentation in the
management of material disposition, process updates, Client's and
CAPA.
- Complete on time project updates, development plans,
self-assessments, and successful completion of all training
requirements.
- Application of statistical and analytical methods such as SPC,
SQC and DOE.
- Contributor to the Capital Expense Request (CER) process,
specify cost for packaging/labeling/sealing equipment with
consideration to product standard cost targets and capacity
demands.
Requirments:
- BS Degree in Packaging Science, Mechanical Engineering or
Equivalent or MS Engineering Preferred
- Min 3 yrs. Applicable Experience in packaging engineering,
medical devices, pharmaceutical or related industry
preferred.
- Broad knowledge of Mechanical/Manufacturing
Engineering.
- Dynamic, positive attitude
- Strong communication, manufacturing process, product
industrialization and leadership skills.
- Solid design, troubleshooting and presentation skills
- Strong leadership skills and able to take direction
- Knowledge of Lean and/or 6 Sigma
- Knowledge of GD&T
- Knowledge of DFMEA and PFMEA
- Strong Project Skills
- Knowledge and Experience with packaging, assembly and
manufacturing methods/equipment (ie: Sencorp bar sealers, Alloyd
blister sealers and material sealing of PETG to Tyvek, foil to
Tyvek, foil to foil, mylar to Tyvek) and Vision Systems.
- Knowledge and Experience with packaging material process and
testing.
- Engineering and Problem-solving tools: MINITAB, SIX SIGMA, DOE,
GR&R, CAPA, CAD, DMAIC
- Experience with DFMA and Lean manufacturing tools.
- Excellent organization, Planning, Computer skills, technical
writing, Communication and Presentation skills.
Keywords: Katalyst Healthcares & Life Sciences, New England , Mid-Level Packaging Engineer, Engineering , North Haven, Northeast
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