Senior Manufacturing Engineer
Company: Katalyst Healthcares & Life Sciences
Posted on: May 19, 2023
Roles & Responsibilities :
- The Manufacturing Engineer will play a key role in supporting
existing processes for the casting of medical device
- Conducts and directs minor sections of new manufacturing
process development projects and assists in performing more complex
engineering projects to evaluate, select, and adapt standard
manufacturing techniques, procedures, and criteria to increase the
efficiency of plant operations.
- Analyzes new processes, technologies, and equipment with the
intent of achieving continuous improvement of present methods using
process cost evaluation, quality and capability alternatives
analyses, and process characterization.
- Assignments usually include one or more of the following:
equipment design and development, the test of materials,
preparation of specifications, process study, research
investigations, and report preparation.
- Provides process engineering support of existing processes and
supports activities related to the development of new processes
including researching the current and emerging technologies, and
evaluating process cost, quality, and capability
- Works in a manufacturing environment in compliance with the
Quality System Regulation (QSR), Standard Operating Procedures
(SOP), and applicable Work Instructions.
- Provides day-to-day support to a limited number of types of
operations as e.g. but not limited to turning, milling, drilling,
EDM, finishing, packaging, etc. as required in support of the
- Studies operations sequence, material flow, functional
statements, organization charts, and project information to
determine worker functions and responsibilities.
- Identifies and assists in instituting state-of-the-art new and
innovative manufacturing technologies as well as process
improvements for existing manufacturing processes utilizing
appropriate engineering principles and standard strategies e.g.
Lean and 5S principles.
- Helps develop project schedules and assists in tracking costs,
preparing status reports, conducting meetings, documenting, and
communicating progress to management.
- Performs process tests along with associated inspection,
process control, documentation, and data collection
- Assists in developing fixturing and tooling design concepts and
has the ability to express and implement ideas with tool
- Supports new equipment acquisition efforts including machine
selection, installation, validation,
- employee training, and other related equipment responsibilities
- Assists Quality Engineers in gage design, gage R&R, and
- Assists in the development of SOPs, other control processes,
and practices as it pertains to a certain defined cell or
- Interfaces regularly with other Manufacturing Engineers,
Manufacturing and Engineering Supervisors, QA Inspectors, and
Product Development Engineers.
- Acts as a liaison to vendors with regard to contracted
products, tools & fixtures, and their manufacture.
Education & Experience :
- BS Degree in Manufacturing Engineering, Mechanical Engineering,
Industrial Engineering, or a related field required.
- 3 to 5 years of relevant experience is preferred.
- Previous experience in manufacturing and/or engineering
manufacturing (internships, co-ops, practical experience) in
Medical Device Industry is preferred.
- Strong written, verbal communication, and computer
- Previous experience in Medical device and/or pharmaceutical
environment is required.
- Hands-on startup and troubleshooting skills in a manufacturing
environment are required.
- Experience in a CNC manufacturing environment is
- CAPA-related experience, risk assessment, and process
validation are required.
Skills Required :
- EU-MDR, CNC programming, Quality System Requirements (QSR),
Manufacturing Materials, Lean Manufacturing, Six Sigma, inventory
optimization, Production NC, CAPA, Regulatory Requirements,
Verification & Validation, Medical devices Engineering change
process, Medical Devices Quality Management, Design controls,
problem solving skills, etc.
Keywords: Katalyst Healthcares & Life Sciences, Brockton , Senior Manufacturing Engineer, Engineering , Raynham, Massachusetts
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