Sr. Manufacturing Engineer
Company: Freudenberg Group
Posted on: March 13, 2023
Empowering people, creating technology.
- Review proposed new tooling/tooling modifications and repairs
to determine the level of validation necessary and coordinate with
other functional departments to develop and implement validation
- Develop validation protocols and reports (IQ/OQ/PQ -
Installation Qualification, Operational Qualification, Performance
Qualification) and provide objective evidence that equipment,
processes, test methods and product meet requirements and are
complaint with applicable regulations.
- Prepare procedures related to process, equipment, test methods
- The investigation of EO/DCN(Engineering Change/Document Change
Notice) received in the Manufacturing Engineering department, their
rejection or approval, development and implementation of any
process changes and proper documentation of any such changes.
- Initiate improvements in current manufacturing methods and
process to improve part quality, schedule performance and to reduce
- Initiate, control and execute validation processes and
procedures for engineering as required by FDA.
- Strong in authoring validation strategies, DOE, FMEA risk
assessments, , technical completion reports, data analysis and
- Ability to support manufacturing, engineering and product
development to implement new or changing processes.
- Ability to review production data and provide recommendations
for process control and process parameters. Qualifications:
- Engineering Bachelor of Science degree, preferably Industrial,
Manufacturing or Mechanical Engineering.
- Minimum 4 to 7 years experience working as a process,
validation, tooling or manufacturing engineer in a manufacturing
environment. Must have at least 3 years experience writing
validations (from start to finish)
- Strong in authoring validation protocols and reports, DOE, FMEA
risk assessments, , technical report authoring, strong statistical
data analysis and recommendation reports.
- Must understand the following regulations: FDA regulations 21
CFR 820; ISO 13485; ISO 14971, GMP
- Knowledge of multiple types of silicone injection molding
machines, ultrasonic equipment, advanced measurement systems
- Technical experience in tooling and process validation.
- Project management skills
- Demonstrated oral and written communication skills and
- Accurate and attentive to detail.
- Good written and spoken communication skills.
- Work with minimal supervision.
- Make educated decisions based on data.
- Mechanical aptitude. Preferred Qualifications:
- 2D/3D CAD and Solid Works experience.
- Six Sigma Green Belt or Black belt Certification.
The Freudenberg Group is an equal opportunity employer that is
committed to diversity and inclusion. Employment opportunities are
available to all applicants and associates without regard to race,
color, religion, creed, gender (including pregnancy, childbirth,
breastfeeding, or related medical conditions), gender identity or
expression, national origin, ancestry, age, mental or physical
disability, genetic information, marital status, familial status,
sexual orientation, protected military or veteran status, or any
other characteristic protected by applicable law.
Freudenberg Medical LLC
Keywords: Freudenberg Group, Santa Barbara , Sr. Manufacturing Engineer, Engineering , Carpinteria, California
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